Trial Outcomes & Findings for To Evaluate Oral Health and Quality of Life Associated With Use of a Denture Adhesive (NCT NCT03807700)
NCT ID: NCT03807700
Last Updated: 2021-09-05
Results Overview
Gum comfort questionnaire was referred to assess the gum health of the denture wearer and to compare the ability of an experimental denture adhesive to provide self-perceived mucosal benefits compared to the use of no adhesive after 12 weeks of product use. It was comprised of 5 questions- Q1: My gums feel comfortable when wearing my denture(s), Q2: I feel my gums are cushioned from the impact of chewing and biting; Q3: My gums do not feel sore at the end of the day; Q4: My gums are not irritated by trapped food particles under my denture(s); Q5: My gums do not feel tired at the end of the day. The participants recorded the response on scale of 0-4: 0-Agree Strongly, 1-Agree Somewhat, 2-Neither Agree or Disagree, 3-Disagree Somewhat, 4- Disagree Strongly). Total score range is 0-20 where lower score indicated better results.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
119 participants
Primary outcome timeframe
At Baseline and after 12 weeks
Results posted on
2021-09-05
Participant Flow
Participants were recruited from a single center in Canada. A total of 119 participants were screened, all of which were enrolled and randomized into the study.
Participants were allocated to randomized treatment in 2 different arms- experimental adhesive group and no adhesive group.
Participant milestones
| Measure |
Experimental Denture Adhesive
In this arm, participants applied denture adhesive in continuous strips to their dentures once per day and then pressed dentures into their mouth and bit firmly to secure the denture hold. Participants recorded their denture cleaning and adhesive application in a study diary for 12 weeks.
|
No Adhesive
In this arm participants refrained from using denture adhesive. The participants recorded their denture cleaning occasions in a study diary for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
59
|
|
Overall Study
COMPLETED
|
58
|
58
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Experimental Denture Adhesive
In this arm, participants applied denture adhesive in continuous strips to their dentures once per day and then pressed dentures into their mouth and bit firmly to secure the denture hold. Participants recorded their denture cleaning and adhesive application in a study diary for 12 weeks.
|
No Adhesive
In this arm participants refrained from using denture adhesive. The participants recorded their denture cleaning occasions in a study diary for 12 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
To Evaluate Oral Health and Quality of Life Associated With Use of a Denture Adhesive
Baseline characteristics by cohort
| Measure |
Experimental Denture Adhesive
n=60 Participants
In this arm, participants applied denture adhesive in continuous strips to their dentures once per day and then pressed dentures into their mouth and bit firmly to secure the denture hold. Participants recorded their denture cleaning and adhesive application in a study diary for 12 weeks.
|
No Adhesive
n=59 Participants
In this arm participants refrained from using denture adhesive. The participants recorded their denture cleaning occasions in a study diary for 12 weeks.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.7 Years
STANDARD_DEVIATION 9.45 • n=99 Participants
|
67.0 Years
STANDARD_DEVIATION 8.56 • n=107 Participants
|
66.8 Years
STANDARD_DEVIATION 8.98 • n=206 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
116 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At Baseline and after 12 weeksPopulation: Analysis was performed on modified intent-to-treat (mITT) population which included all randomized participants who received at least one dose of study product and had at least one post randomization measure of gum comfort recorded via the questionnaire. Number analyzed included participants with available data for each specified category.
Gum comfort questionnaire was referred to assess the gum health of the denture wearer and to compare the ability of an experimental denture adhesive to provide self-perceived mucosal benefits compared to the use of no adhesive after 12 weeks of product use. It was comprised of 5 questions- Q1: My gums feel comfortable when wearing my denture(s), Q2: I feel my gums are cushioned from the impact of chewing and biting; Q3: My gums do not feel sore at the end of the day; Q4: My gums are not irritated by trapped food particles under my denture(s); Q5: My gums do not feel tired at the end of the day. The participants recorded the response on scale of 0-4: 0-Agree Strongly, 1-Agree Somewhat, 2-Neither Agree or Disagree, 3-Disagree Somewhat, 4- Disagree Strongly). Total score range is 0-20 where lower score indicated better results.
Outcome measures
| Measure |
Experimental Denture Adhesive
n=59 Participants
In this arm, participants applied denture adhesive in continuous strips to their dentures once per day and then pressed dentures into their mouth and bit firmly to secure the denture hold. Participants recorded their denture cleaning and adhesive application in a study diary for 12 weeks.
|
No Adhesive
n=58 Participants
In this arm participants refrained from using denture adhesive. The participants recorded their denture cleaning occasions in a study diary for 12 weeks.
|
|---|---|---|
|
Gum Health Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the Gum Comfort Questionnaire After 12 Weeks
Baseline
|
4.1 Score on scale
Standard Deviation 4.22
|
4.5 Score on scale
Standard Deviation 3.55
|
|
Gum Health Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the Gum Comfort Questionnaire After 12 Weeks
Change from baseline after week 12
|
-0.6 Score on scale
Standard Deviation 3.08
|
-0.4 Score on scale
Standard Deviation 4.16
|
SECONDARY outcome
Timeframe: At Baseline and after 1 week, 4 weeks and 8 weeksPopulation: Analysis was performed on mITT population which included all randomized participants who received at least one dose of study product and had at least one post randomization measure of gum comfort recorded via the questionnaire. Number analyzed included participants with available data for each specified category.
Gum comfort questionnaire was referred to assess the gum health of the denture wearer and to compare the ability of an experimental denture adhesive to provide self-perceived mucosal benefits compared to the use of no adhesive after 1, 4 and 8 weeks of product use. It was comprised of 5 questions- Q1: My gums feel comfortable when wearing my denture(s), Q2: I feel my gums are cushioned from the impact of chewing and biting; Q3: My gums do not feel sore at the end of the day; Q4: My gums are not irritated by trapped food particles under my denture(s); Q5: My gums do not feel tired at the end of the day. The participants recorded the response on scale of 0-4: 0-Agree Strongly, 1-Agree Somewhat, 3-Neither Agree or Disagree, 4= Disagree Strongly). Total score range is 0-20 where lower score indicated better results.
Outcome measures
| Measure |
Experimental Denture Adhesive
n=59 Participants
In this arm, participants applied denture adhesive in continuous strips to their dentures once per day and then pressed dentures into their mouth and bit firmly to secure the denture hold. Participants recorded their denture cleaning and adhesive application in a study diary for 12 weeks.
|
No Adhesive
n=58 Participants
In this arm participants refrained from using denture adhesive. The participants recorded their denture cleaning occasions in a study diary for 12 weeks.
|
|---|---|---|
|
Gum Health Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the Gum Comfort Questionnaire After 1, 4 and 8 Weeks
Change from baseline after week 1
|
-0.5 Score on scale
Standard Deviation 2.95
|
-0.3 Score on scale
Standard Deviation 1.67
|
|
Gum Health Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the Gum Comfort Questionnaire After 1, 4 and 8 Weeks
Change from baseline after week 4
|
-1.0 Score on scale
Standard Deviation 3.46
|
-0.2 Score on scale
Standard Deviation 2.47
|
|
Gum Health Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the Gum Comfort Questionnaire After 1, 4 and 8 Weeks
Change from baseline after week 8
|
-1.0 Score on scale
Standard Deviation 3.44
|
-0.4 Score on scale
Standard Deviation 3.34
|
SECONDARY outcome
Timeframe: At Baseline and after 1 week, 4 weeks, 8 weeks and 12 weeksPopulation: Analysis was performed on mITT population which included all randomized participants who received at least one dose of study product and had at least one post randomization measure of gum comfort recorded via the questionnaire. Number analyzed included participants with available data for each specified category.
Gum comfort questionnaire was referred to assess the gum health of the denture wearer and to compare the ability of an experimental denture adhesive to provide self-perceived mucosal benefits compared to the use of no adhesive after 1, 4, 8 and 12 weeks of product use. It was comprised of 5 questions- Q1: My gums feel comfortable when wearing my denture(s), Q2: I feel my gums are cushioned from the impact of chewing and biting; Q3: My gums do not feel sore at the end of the day; Q4: My gums are not irritated by trapped food particles under my denture(s); Q5: My gums do not feel tired at the end of the day. The participants recorded the response on scale of 0-4: 0-Agree Strongly, 1-Agree Somewhat, 3-Neither Agree or Disagree, 4= Disagree Strongly). Total score range is 0-20 where lower score indicated better results.
Outcome measures
| Measure |
Experimental Denture Adhesive
n=59 Participants
In this arm, participants applied denture adhesive in continuous strips to their dentures once per day and then pressed dentures into their mouth and bit firmly to secure the denture hold. Participants recorded their denture cleaning and adhesive application in a study diary for 12 weeks.
|
No Adhesive
n=58 Participants
In this arm participants refrained from using denture adhesive. The participants recorded their denture cleaning occasions in a study diary for 12 weeks.
|
|---|---|---|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q1: Baseline
|
0.6 Score on scale
Standard Deviation 0.95
|
0.6 Score on scale
Standard Deviation 0.8
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q1: Change from BL after week 1
|
-0.1 Score on scale
Standard Deviation 0.86
|
0.1 Score on scale
Standard Deviation 0.45
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q1: Change from BL after week 4
|
-0.1 Score on scale
Standard Deviation 0.81
|
0.1 Score on scale
Standard Deviation 0.66
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q1: Change from BL after week 8
|
-0.0 Score on scale
Standard Deviation 0.84
|
-0.1 Score on scale
Standard Deviation 0.66
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q1: Change from BL after week 12
|
-0.1 Score on scale
Standard Deviation 0.81
|
0.0 Score on scale
Standard Deviation 0.95
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q2: Baseline
|
0.9 Score on scale
Standard Deviation 0.99
|
1.0 Score on scale
Standard Deviation 0.79
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q2: Change from BL after week 1
|
-0.1 Score on scale
Standard Deviation 1.02
|
-0.1 Score on scale
Standard Deviation 0.76
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q2: Change from BL after week 4
|
-0.3 Score on scale
Standard Deviation 1.05
|
0.1 Score on scale
Standard Deviation 0.92
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q2: Change from BL after week 8
|
-0.1 Score on scale
Standard Deviation 1.27
|
0.0 Score on scale
Standard Deviation 1.23
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q2: Change from BL after week 12
|
-0.2 Score on scale
Standard Deviation 1.20
|
-0.0 Score on scale
Standard Deviation 1.13
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q3: Baseline
|
0.6 Score on scale
Standard Deviation 0.99
|
0.6 Score on scale
Standard Deviation 0.82
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q3: Change from BL after week 1
|
0.0 Score on scale
Standard Deviation 0.78
|
0.1 Score on scale
Standard Deviation 0.79
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q3: Change from BL after week 4
|
-0.1 Score on scale
Standard Deviation 0.98
|
0.2 Score on scale
Standard Deviation 0.85
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q3: Change from BL after week 8
|
-0.1 Score on scale
Standard Deviation 0.88
|
0.2 Score on scale
Standard Deviation 0.90
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q3: Change from BL after week 12
|
0.0 Score on scale
Standard Deviation 0.88
|
0.1 Score on scale
Standard Deviation 1.11
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q4: Baseline
|
1.3 Score on scale
Standard Deviation 1.23
|
1.5 Score on scale
Standard Deviation 1.05
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q4: Change from BL after week 1
|
-0.2 Score on scale
Standard Deviation 0.96
|
-0.2 Score on scale
Standard Deviation 0.88
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q4: Change from BL after week 4
|
-0.3 Score on scale
Standard Deviation 1.01
|
-0.4 Score on scale
Standard Deviation 0.96
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q4: Change from BL after week 8
|
-0.4 Score on scale
Standard Deviation 1.07
|
-0.4 Score on scale
Standard Deviation 1.08
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q4: Change from BL after week 12
|
-0.2 Score on scale
Standard Deviation 1.01
|
-0.3 Score on scale
Standard Deviation 1.28
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q5: Baseline
|
0.8 Score on scale
Standard Deviation 1.05
|
0.8 Score on scale
Standard Deviation 1.02
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q5: Change from BL after week 1
|
-0.2 Score on scale
Standard Deviation 1.05
|
-0.1 Score on scale
Standard Deviation 0.65
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q5: Change from BL after week 4
|
-0.2 Score on scale
Standard Deviation 1.10
|
-0.1 Score on scale
Standard Deviation 0.77
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q5: Change from BL after week 8
|
-0.3 Score on scale
Standard Deviation 1.03
|
-0.1 Score on scale
Standard Deviation 1.00
|
|
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
Q5: Change from BL after week 12
|
-0.2 Score on scale
Standard Deviation 0.95
|
-0.1 Score on scale
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: At Baseline and after 1 week, 4 weeks, 8 weeks and 12 weeksPopulation: Analysis was performed on mITT population which included all randomized participants who received at least one dose of study product and had at least one post randomization measure of gum comfort recorded via the questionnaire. Number analyzed included participants with available data for each specified category.
MSA used by dentist to assess health of denture bearing tissues of participants across whole mouth on scale:1-4,1- normal appearance of gingiva,oral mucosa,2-mild inflammation(slight redness and/or hypertrophy/hyperplasia of gingiva and slight redness in some areas of palatal mucosa,including red spots indicating inflamed salivary duct orifices),3-moderate inflammation(marked redness and hypertrophy/hyperplasia of the gingiva, in large ares of palate, in oral mucosa, ulceration caused by denture, red and inflamed fibro-epithelial hyperplasia caused by denture),4-severe inflammation(severe redness and hypertrophy/hyperplasia of gingiva,spontaneous gingival bleeding, marked palatal granulations, inflamed oral mucosa areas).MSA was performed on denture-bearing tissues for either/both dentures across whole mouth and examiner recorded highest applicable score. Lower score indicated better results.
Outcome measures
| Measure |
Experimental Denture Adhesive
n=59 Participants
In this arm, participants applied denture adhesive in continuous strips to their dentures once per day and then pressed dentures into their mouth and bit firmly to secure the denture hold. Participants recorded their denture cleaning and adhesive application in a study diary for 12 weeks.
|
No Adhesive
n=58 Participants
In this arm participants refrained from using denture adhesive. The participants recorded their denture cleaning occasions in a study diary for 12 weeks.
|
|---|---|---|
|
Mucosal Health Analysis of Denture Bearing Tissues by Change From Baseline in Mucosal Score Assessment (MSA) After 1, 4, 8 and 12 Weeks
Baseline
|
1.8 Score on scale
Standard Deviation 0.78
|
1.7 Score on scale
Standard Deviation 0.71
|
|
Mucosal Health Analysis of Denture Bearing Tissues by Change From Baseline in Mucosal Score Assessment (MSA) After 1, 4, 8 and 12 Weeks
Change from baseline after week 1
|
-0.1 Score on scale
Standard Deviation 0.55
|
0.0 Score on scale
Standard Deviation 0.61
|
|
Mucosal Health Analysis of Denture Bearing Tissues by Change From Baseline in Mucosal Score Assessment (MSA) After 1, 4, 8 and 12 Weeks
Change from baseline after week 4
|
-0.2 Score on scale
Standard Deviation 0.78
|
-0.1 Score on scale
Standard Deviation 0.66
|
|
Mucosal Health Analysis of Denture Bearing Tissues by Change From Baseline in Mucosal Score Assessment (MSA) After 1, 4, 8 and 12 Weeks
Change from baseline after week 8
|
-0.2 Score on scale
Standard Deviation 0.73
|
-0.1 Score on scale
Standard Deviation 0.63
|
|
Mucosal Health Analysis of Denture Bearing Tissues by Change From Baseline in Mucosal Score Assessment (MSA) After 1, 4, 8 and 12 Weeks
Change from baseline after week 12
|
-0.3 Score on scale
Standard Deviation 0.64
|
-0.1 Score on scale
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: At Baseline and after 1 week, 4 weeks, 8 weeks and 12 weeksPopulation: Analysis was performed on mITT population which included all randomized participants who received at least one dose of study product and had at least one post randomization measure of gum comfort recorded via the questionnaire. Number analyzed included participants with available data for each specified category.
OHIP-Edent questionnaire was used for the evaluation of OHrQoL. This questionnaire was comprised of 19 questions grouped into 6 functional domains and the participants responded on the scale of 0-4: 0-never, 1-rarely, 2-occasionally, 3-often and 4-very often. The functional domains are: domain 1- functional limitations (questions 1-3, score range 0-12), domain 2- physical pain (questions 4-7, score range 0-16), domain 3- psychological discomfort (questions 8-9, score range 0-8), domain 4- physical disability (questions 10-12, score range 0-12), domain 5- psychological disability (questions 13-14, score range 0-8) and domain 6- social disability (questions 15-19, score range 0-20). The overall score range is 0-76 where 0 is the best possible score. Lower scores represent a more favorable perception of participants OHrQoL.
Outcome measures
| Measure |
Experimental Denture Adhesive
n=59 Participants
In this arm, participants applied denture adhesive in continuous strips to their dentures once per day and then pressed dentures into their mouth and bit firmly to secure the denture hold. Participants recorded their denture cleaning and adhesive application in a study diary for 12 weeks.
|
No Adhesive
n=58 Participants
In this arm participants refrained from using denture adhesive. The participants recorded their denture cleaning occasions in a study diary for 12 weeks.
|
|---|---|---|
|
Oral Health Related Quality of Life (OHrQoL) Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the Oral Health Impact Profile for Edentulous Patients (OHIP)-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Baseline
|
17.3 Score on scale
Standard Deviation 12.79
|
15.7 Score on scale
Standard Deviation 8.61
|
|
Oral Health Related Quality of Life (OHrQoL) Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the Oral Health Impact Profile for Edentulous Patients (OHIP)-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Change from baseline after week 1
|
-2.7 Score on scale
Standard Deviation 9.16
|
-1.3 Score on scale
Standard Deviation 3.72
|
|
Oral Health Related Quality of Life (OHrQoL) Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the Oral Health Impact Profile for Edentulous Patients (OHIP)-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Change from baseline after week 4
|
-3.5 Score on scale
Standard Deviation 9.32
|
-1.9 Score on scale
Standard Deviation 5.23
|
|
Oral Health Related Quality of Life (OHrQoL) Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the Oral Health Impact Profile for Edentulous Patients (OHIP)-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Change from baseline after week 8
|
-3.6 Score on scale
Standard Deviation 7.62
|
-2.4 Score on scale
Standard Deviation 5.85
|
|
Oral Health Related Quality of Life (OHrQoL) Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the Oral Health Impact Profile for Edentulous Patients (OHIP)-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Change from baseline after week 12
|
-3.2 Score on scale
Standard Deviation 8.23
|
-2.9 Score on scale
Standard Deviation 8.60
|
SECONDARY outcome
Timeframe: At Baseline and after 1 week, 4 weeks, 8 weeks and 12 weeksPopulation: Analysis was performed on mITT population which included all randomized participants who received at least one dose of study product and had at least one post randomization measure of gum comfort recorded via the questionnaire. Number analyzed included participants with available data for each specified category.
OHIP-Edent questionnaire was used for the evaluation of OHrQoL. This questionnaire was comprised of 19 questions grouped into 6 functional domains and the participants responded on the scale of 0-4: 0-never, 1-rarely, 2-occasionally, 3-often and 4-very often. The functional domains are: domain 1- functional limitations (questions 1-3, score range 0-12), domain 2- physical pain (questions 4-7, score range 0-16), domain 3- psychological discomfort (questions 8-9, score range 0-8), domain 4- physical disability (questions 10-12, score range 0-12), domain 5- psychological disability (questions 13-14, score range 0-8) and domain 6- social disability (questions 15-19, score range 0-20). The overall score range is 0-76 where 0 is the best possible score. Lower scores represent a more favorable perception of participants OHrQoL.
Outcome measures
| Measure |
Experimental Denture Adhesive
n=59 Participants
In this arm, participants applied denture adhesive in continuous strips to their dentures once per day and then pressed dentures into their mouth and bit firmly to secure the denture hold. Participants recorded their denture cleaning and adhesive application in a study diary for 12 weeks.
|
No Adhesive
n=58 Participants
In this arm participants refrained from using denture adhesive. The participants recorded their denture cleaning occasions in a study diary for 12 weeks.
|
|---|---|---|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Functional Limitations: Baseline (BL)
|
3.6 Score on scale
Standard Deviation 2.85
|
3.9 Score on scale
Standard Deviation 2.01
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Functional Limitations:Change from BL after week1
|
-0.4 Score on scale
Standard Deviation 2.25
|
-0.6 Score on scale
Standard Deviation 1.38
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Functional Limitations:Change from BL after week4
|
-0.7 Score on scale
Standard Deviation 2.32
|
-0.8 Score on scale
Standard Deviation 1.75
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Functional Limitations:Change from BL after week8
|
-0.7 Score on scale
Standard Deviation 2.04
|
-0.9 Score on scale
Standard Deviation 1.55
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Functional Limitations:Change from BL after week12
|
-0.7 Score on scale
Standard Deviation 2.09
|
-1.0 Score on scale
Standard Deviation 2.09
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Physical pain: Baseline
|
3.6 Score on scale
Standard Deviation 2.89
|
3.7 Score on scale
Standard Deviation 2.43
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Physical pain: Change from BL after week1
|
-0.5 Score on scale
Standard Deviation 2.31
|
-0.3 Score on scale
Standard Deviation 1.62
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Physical pain: Change from BL after week4
|
-0.8 Score on scale
Standard Deviation 2.49
|
-0.4 Score on scale
Standard Deviation 1.75
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Physical pain: Change from BL after week8
|
-0.8 Score on scale
Standard Deviation 2.07
|
-0.4 Score on scale
Standard Deviation 1.74
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Physical pain: Change from BL after week12
|
-0.7 Score on scale
Standard Deviation 2.08
|
-0.6 Score on scale
Standard Deviation 2.50
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Psychological (Psych) discomfort: Baseline
|
2.1 Score on scale
Standard Deviation 2.15
|
2.2 Score on scale
Standard Deviation 1.74
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Psych discomfort:Change from BL after week1
|
-0.3 Score on scale
Standard Deviation 1.85
|
-0.4 Score on scale
Standard Deviation 1.01
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Psych discomfort:Change from BL after week4
|
-0.2 Score on scale
Standard Deviation 1.58
|
-0.7 Score on scale
Standard Deviation 1.22
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Psych discomfort:Change from BL after week8
|
-0.3 Score on scale
Standard Deviation 1.62
|
-0.7 Score on scale
Standard Deviation 1.24
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Psych discomfort:Change from BL after week12
|
-0.2 Score on scale
Standard Deviation 1.38
|
-0.8 Score on scale
Standard Deviation 1.56
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Physical disability: Baseline
|
3.2 Score on scale
Standard Deviation 2.60
|
2.5 Score on scale
Standard Deviation 1.91
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Physical disability:Change from BL after week1
|
-0.3 Score on scale
Standard Deviation 2.14
|
-0.1 Score on scale
Standard Deviation 1.14
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Physical disability:Change from BL after week4
|
-0.5 Score on scale
Standard Deviation 2.06
|
-0.2 Score on scale
Standard Deviation 1.39
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Physical disability:Change from BL after week8
|
-0.7 Score on scale
Standard Deviation 1.74
|
-0.3 Score on scale
Standard Deviation 1.69
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Physical disability:Change from BL after week12
|
-0.7 Score on scale
Standard Deviation 2.15
|
-0.4 Score on scale
Standard Deviation 1.90
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Psychological (Psych) disability: Baseline
|
1.8 Score on scale
Standard Deviation 2.09
|
1.6 Score on scale
Standard Deviation 1.33
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Psych disability:Change from BL after week1
|
-0.4 Score on scale
Standard Deviation 1.65
|
0.0 Score on scale
Standard Deviation 0.92
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Psych disability:Change from BL after week4
|
-0.4 Score on scale
Standard Deviation 1.65
|
-0.2 Score on scale
Standard Deviation 1.05
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Psych disability:Change from BL after week8
|
-0.5 Score on scale
Standard Deviation 1.48
|
-0.3 Score on scale
Standard Deviation 1.03
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Psych disability:Change from BL after week12
|
-0.4 Score on scale
Standard Deviation 1.77
|
-0.4 Score on scale
Standard Deviation 1.27
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Social disability: Baseline
|
2.9 Score on scale
Standard Deviation 3.17
|
1.9 Score on scale
Standard Deviation 2.39
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Social disability:Change from BL after week1
|
-0.7 Score on scale
Standard Deviation 2.37
|
0.1 Score on scale
Standard Deviation 1.13
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Social disability:Change from BL after week4
|
-0.9 Score on scale
Standard Deviation 2.20
|
0.4 Score on scale
Standard Deviation 1.97
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Social disability:Change from BL after week8
|
-0.6 Score on scale
Standard Deviation 2.09
|
0.2 Score on scale
Standard Deviation 1.99
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks
Social disability:Change from BL after week12
|
-0.4 Score on scale
Standard Deviation 2.30
|
0.3 Score on scale
Standard Deviation 2.32
|
SECONDARY outcome
Timeframe: At Baseline and after 1 week, 4 weeks, 8 weeks and 12 weeksPopulation: Analysis was performed on mITT population which included all randomized participants who received at least one dose of study product and had at least one post randomization measure of gum comfort recorded via the questionnaire. Number analyzed included participants with available data for each specified category.
GOHAI questionnaire was used for the evaluation of OHrQoL. It was comprised of 12 questions with 6 possible responses. The participants responded on the scale of 0-5: 0-always, 1-very often, 2-often, 3-sometimes, 4-seldom and 5-never. The functional domain of the questionnaire are as: domain 1: functional (questions 1-4, score range 0-20, participant's ability to eat, speak and swallow); domain 2: psychological (questions 6,7,9-11, score range 0-25, participant's concerns, relationships and appearance); domain 3- pain/ discomfort (questions 5,8,12, score range 0-15, participant's discomfort during chewing, sensitivity to hot/cold/sweets and use of medications to manage oral pain). The responses were scored on a 0 (always)-5 (never) scale for all questions except 3, 5 and 7 where the scoring is reversed, and thus the range of scores for the questionnaire is 0-60, where 60 is the best possible score. Higher score indicated better results.
Outcome measures
| Measure |
Experimental Denture Adhesive
n=59 Participants
In this arm, participants applied denture adhesive in continuous strips to their dentures once per day and then pressed dentures into their mouth and bit firmly to secure the denture hold. Participants recorded their denture cleaning and adhesive application in a study diary for 12 weeks.
|
No Adhesive
n=58 Participants
In this arm participants refrained from using denture adhesive. The participants recorded their denture cleaning occasions in a study diary for 12 weeks.
|
|---|---|---|
|
OHrQoL Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the General Oral Health Assessment Index (GOHAI) Questionnaires After 1, 4, 8 and 12 Weeks
Baseline
|
46.3 Score on scale
Standard Deviation 8.16
|
48.6 Score on scale
Standard Deviation 6.93
|
|
OHrQoL Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the General Oral Health Assessment Index (GOHAI) Questionnaires After 1, 4, 8 and 12 Weeks
Change from baseline after week 1
|
0.8 Score on scale
Standard Deviation 5.89
|
0.2 Score on scale
Standard Deviation 3.57
|
|
OHrQoL Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the General Oral Health Assessment Index (GOHAI) Questionnaires After 1, 4, 8 and 12 Weeks
Change from baseline after week 4
|
1.9 Score on scale
Standard Deviation 6.34
|
0.7 Score on scale
Standard Deviation 5.55
|
|
OHrQoL Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the General Oral Health Assessment Index (GOHAI) Questionnaires After 1, 4, 8 and 12 Weeks
Change from baseline after week 8
|
2.9 Score on scale
Standard Deviation 6.20
|
1.1 Score on scale
Standard Deviation 6.19
|
|
OHrQoL Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the General Oral Health Assessment Index (GOHAI) Questionnaires After 1, 4, 8 and 12 Weeks
Change from baseline after week 12
|
2.5 Score on scale
Standard Deviation 7.38
|
0.9 Score on scale
Standard Deviation 6.82
|
SECONDARY outcome
Timeframe: At Baseline and after 1 week, 4 weeks, 8 weeks and 12 weeksPopulation: Analysis was performed on mITT population which included all randomized participants who received at least one dose of study product and had at least one post randomization measure of gum comfort recorded via the questionnaire. Number analyzed included participants with available data for each specified category.
GOHAI questionnaire was used for the evaluation of OHrQoL. It was comprised of 12 questions with 6 possible responses. The participants responded on the scale of 0-5: 0-always, 1-very often, 2-often, 3-sometimes, 4-seldom and 5-never. The functional domain of the questionnaire are as: domain 1: functional (questions 1-4, score range 0-20, participant's ability to eat, speak and swallow); domain 2: psychological (questions 6,7,9-11, score range 0-25, participant's concerns, relationships and appearance); domain 3- pain/ discomfort (questions 5,8,12, score range 0-15, participant's discomfort during chewing, sensitivity to hot/cold/sweets and use of medications to manage oral pain). The responses were scored on a 0 (always)-5 (never) scale for all questions except 3, 5 and 7 where the scoring is reversed, and thus the range of scores for the questionnaire is 0-60, where 60 is the best possible score. Higher score indicated better results.
Outcome measures
| Measure |
Experimental Denture Adhesive
n=59 Participants
In this arm, participants applied denture adhesive in continuous strips to their dentures once per day and then pressed dentures into their mouth and bit firmly to secure the denture hold. Participants recorded their denture cleaning and adhesive application in a study diary for 12 weeks.
|
No Adhesive
n=58 Participants
In this arm participants refrained from using denture adhesive. The participants recorded their denture cleaning occasions in a study diary for 12 weeks.
|
|---|---|---|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the GOHAI Questionnaires After 1, 4, 8 and 12 Weeks
Functional domain: Baseline (BL)
|
14.9 Score on scale
Standard Deviation 3.63
|
15.8 Score on scale
Standard Deviation 3.11
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the GOHAI Questionnaires After 1, 4, 8 and 12 Weeks
Functional domain:Change from BL after week1
|
0.6 Score on scale
Standard Deviation 3.21
|
-0.1 Score on scale
Standard Deviation 1.92
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the GOHAI Questionnaires After 1, 4, 8 and 12 Weeks
Functional domain:Change from BL after week4
|
0.9 Score on scale
Standard Deviation 3.07
|
0.7 Score on scale
Standard Deviation 2.86
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the GOHAI Questionnaires After 1, 4, 8 and 12 Weeks
Functional domain:Change from BL after week8
|
1.2 Score on scale
Standard Deviation 3.28
|
0.7 Score on scale
Standard Deviation 2.95
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the GOHAI Questionnaires After 1, 4, 8 and 12 Weeks
Functional domain:Change from BL after week12
|
1.3 Score on scale
Standard Deviation 2.99
|
0.8 Score on scale
Standard Deviation 3.17
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the GOHAI Questionnaires After 1, 4, 8 and 12 Weeks
Psychosocial domain: Baseline
|
20.1 Score on scale
Standard Deviation 4.34
|
20.9 Score on scale
Standard Deviation 3.44
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the GOHAI Questionnaires After 1, 4, 8 and 12 Weeks
Psychosocial domain:Change from BL after week1
|
-0.2 Score on scale
Standard Deviation 2.89
|
0.2 Score on scale
Standard Deviation 1.56
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the GOHAI Questionnaires After 1, 4, 8 and 12 Weeks
Psychosocial domain:Change from BL after week4
|
0.7 Score on scale
Standard Deviation 3.97
|
0.1 Score on scale
Standard Deviation 2.77
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the GOHAI Questionnaires After 1, 4, 8 and 12 Weeks
Psychosocial domain:Change from BL after week8
|
1.1 Score on scale
Standard Deviation 3.68
|
0.3 Score on scale
Standard Deviation 2.98
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the GOHAI Questionnaires After 1, 4, 8 and 12 Weeks
Psychosocial domain:Change from BL after week12
|
0.6 Score on scale
Standard Deviation 3.89
|
0.3 Score on scale
Standard Deviation 3.49
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the GOHAI Questionnaires After 1, 4, 8 and 12 Weeks
Pain/Discomfort domain: Baseline
|
11.3 Score on scale
Standard Deviation 2.49
|
11.8 Score on scale
Standard Deviation 2.12
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the GOHAI Questionnaires After 1, 4, 8 and 12 Weeks
Pain/Discomfort domain:Change from BL after week1
|
0.4 Score on scale
Standard Deviation 1.73
|
0.1 Score on scale
Standard Deviation 2.03
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the GOHAI Questionnaires After 1, 4, 8 and 12 Weeks
Pain/Discomfort domain:Change from BL after week4
|
0.3 Score on scale
Standard Deviation 2.52
|
-0.0 Score on scale
Standard Deviation 1.96
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the GOHAI Questionnaires After 1, 4, 8 and 12 Weeks
Pain/Discomfort domain:Change from BL after week8
|
0.7 Score on scale
Standard Deviation 2.27
|
0.1 Score on scale
Standard Deviation 2.16
|
|
OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the GOHAI Questionnaires After 1, 4, 8 and 12 Weeks
Pain/Discomfort domain:Change from BL after week12
|
0.6 Score on scale
Standard Deviation 2.90
|
-0.3 Score on scale
Standard Deviation 2.42
|
SECONDARY outcome
Timeframe: At week 4Population: Analysis was performed on mITT population of only experimental denture adhesive group. Number analyzed included participants with available data for each specified category.
Sensory attributes of the adhesive was assessed by sensory questionnaire which was comprised of 6 questions; Q1: I feel the product has a smooth texture on my gums, Q2: I feel the product is gentle on my gums, Q3: I feel the product flavor soothes my gums, Q4: I feel the product flavor cools my gums, Q5: I feel the product is easy to apply, Q6: I feel less rubbing from my denture throughout the day when using this product. This questionnaire was only referred to participants randomized to the experimental adhesive group. The participants responded for all questions on the scale of 0-4: 0-agree strongly,1-agree somewhat, 2-neither agree or disagree, 3-disagree somewhat, 4-disagree strongly. The total score range is 0-24 where a low score indicated better results.
Outcome measures
| Measure |
Experimental Denture Adhesive
n=59 Participants
In this arm, participants applied denture adhesive in continuous strips to their dentures once per day and then pressed dentures into their mouth and bit firmly to secure the denture hold. Participants recorded their denture cleaning and adhesive application in a study diary for 12 weeks.
|
No Adhesive
In this arm participants refrained from using denture adhesive. The participants recorded their denture cleaning occasions in a study diary for 12 weeks.
|
|---|---|---|
|
Mean Scores of Participant Responses to the Sensory Questionnaire at Week 4
|
4.7 Score on scale
Standard Deviation 3.30
|
—
|
Adverse Events
Experimental Denture Adhesive
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
No Adhesive
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Overall
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Denture Adhesive
n=60 participants at risk
In this arm, participants applied denture adhesive in continuous strips to their dentures once per day and then pressed dentures into their mouth and bit firmly to secure the denture hold. Participants recorded their denture cleaning and adhesive application in a study diary for 12 weeks.
|
No Adhesive
n=59 participants at risk
In this arm participants refrained from using denture adhesive. The participants recorded their denture cleaning occasions in a study diary for 12 weeks.
|
Overall
n=119 participants at risk
Included all participants that were assessed for safety adverse events.
|
|---|---|---|---|
|
Gastrointestinal disorders
Oral mucosal erythema
|
23.3%
14/60 • Number of events 16 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
25.4%
15/59 • Number of events 16 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
24.4%
29/119 • Number of events 32 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
|
Gastrointestinal disorders
Gingival erythema
|
23.3%
14/60 • Number of events 14 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
11.9%
7/59 • Number of events 8 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
17.6%
21/119 • Number of events 22 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
5.0%
3/60 • Number of events 3 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
8.5%
5/59 • Number of events 5 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
6.7%
8/119 • Number of events 8 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
|
Gastrointestinal disorders
Oral mucosal hypertrophy
|
3.3%
2/60 • Number of events 2 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
1.7%
1/59 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
2.5%
3/119 • Number of events 3 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/60 • Number of events 2 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
0.00%
0/59 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
0.84%
1/119 • Number of events 2 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.7%
1/60 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
0.00%
0/59 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
0.84%
1/119 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
|
Gastrointestinal disorders
Gingival pain
|
1.7%
1/60 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
0.00%
0/59 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
0.84%
1/119 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
|
Gastrointestinal disorders
Gingival ulceration
|
0.00%
0/60 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
1.7%
1/59 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
0.84%
1/119 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
|
Gastrointestinal disorders
Palatal ulcer
|
0.00%
0/60 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
1.7%
1/59 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
0.84%
1/119 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
|
Infections and infestations
Gastroenteritis viral
|
1.7%
1/60 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
0.00%
0/59 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
0.84%
1/119 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
|
Nervous system disorders
Headache
|
1.7%
1/60 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
0.00%
0/59 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
0.84%
1/119 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (or last procedure).
Safety population included all participants who were randomized and received at least one dose of investigational product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious AEs were collected and reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER