Trial Outcomes & Findings for Assessing Effects of a Denture Gel on Gum Abrasions (NCT NCT04913636)
NCT ID: NCT04913636
Last Updated: 2022-06-28
Results Overview
The total number of abrasions pre-food challenge
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
Day 3
Results posted on
2022-06-28
Participant Flow
Participant milestones
| Measure |
Test Group
Treatment Gel: In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.
|
Control Group
Sham Control: Subjects will perform their regular denture cleaning routine.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
20
|
|
Overall Study
COMPLETED
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Subject dropped from experimental leg
Baseline characteristics by cohort
| Measure |
Test Group
n=18 Participants
Treatment Gel: In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.
|
Control Group
n=20 Participants
Sham Control: Subjects will perform their regular denture cleaning routine.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.7 years
STANDARD_DEVIATION 12.39 • n=18 Participants
|
64.4 years
STANDARD_DEVIATION 12.55 • n=20 Participants
|
65.0 years
STANDARD_DEVIATION 12.32 • n=38 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=18 Participants
|
14 Participants
n=20 Participants
|
25 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=18 Participants
|
6 Participants
n=20 Participants
|
13 Participants
n=38 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=38 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=38 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=38 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=18 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=38 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=18 Participants
|
18 Participants
n=20 Participants
|
33 Participants
n=38 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=38 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=38 Participants
|
|
Post-Peanut Gum Abrasion Evaluation (number)
|
5.18 number of abrasions
STANDARD_DEVIATION 3.729 • n=17 Participants • Subject dropped from experimental leg
|
3.85 number of abrasions
STANDARD_DEVIATION 2.700 • n=20 Participants • Subject dropped from experimental leg
|
4.46 number of abrasions
STANDARD_DEVIATION 3.237 • n=37 Participants • Subject dropped from experimental leg
|
|
Post-Peanut Challenge Evaluation (size)
|
9.85 mm
STANDARD_DEVIATION 7.678 • n=17 Participants • Subject dropped from experimental leg
|
5.95 mm
STANDARD_DEVIATION 5.275 • n=20 Participants • Subject dropped from experimental leg
|
7.74 mm
STANDARD_DEVIATION 6.690 • n=37 Participants • Subject dropped from experimental leg
|
PRIMARY outcome
Timeframe: Day 3The total number of abrasions pre-food challenge
Outcome measures
| Measure |
Test Group
n=16 Participants
Treatment Gel: In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.
|
Control Group
n=20 Participants
Sham Control: Subjects will perform their regular denture cleaning routine.
|
|---|---|---|
|
Abrasion Assessment (Number)
|
3.65 number of abrasions
Standard Error .518
|
4.11 number of abrasions
Standard Error .461
|
PRIMARY outcome
Timeframe: Day 3The average size/area (in mm) of the total number of abrasions pre-food challenge
Outcome measures
| Measure |
Test Group
n=16 Participants
Treatment Gel: In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.
|
Control Group
n=20 Participants
Sham Control: Subjects will perform their regular denture cleaning routine.
|
|---|---|---|
|
Abrasion Assessment (Size)
|
6.77 mm
Standard Error .731
|
7.24 mm
Standard Error .653
|
PRIMARY outcome
Timeframe: Day 6The total number of abrasions pre-food challenge
Outcome measures
| Measure |
Test Group
n=15 Participants
Treatment Gel: In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.
|
Control Group
n=18 Participants
Sham Control: Subjects will perform their regular denture cleaning routine.
|
|---|---|---|
|
Abrasion Assessment (Number)
|
2.25 number of abrasions
Standard Error .731
|
3.66 number of abrasions
Standard Error .654
|
PRIMARY outcome
Timeframe: Week 2The total number of abrasions pre-food challenge
Outcome measures
| Measure |
Test Group
n=15 Participants
Treatment Gel: In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.
|
Control Group
n=18 Participants
Sham Control: Subjects will perform their regular denture cleaning routine.
|
|---|---|---|
|
Abrasion Assessment (Number)
|
2.23 number of abrasions
Standard Error .688
|
2.48 number of abrasions
Standard Error .627
|
PRIMARY outcome
Timeframe: Week 4The total number of abrasions pre-food challenge
Outcome measures
| Measure |
Test Group
n=15 Participants
Treatment Gel: In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.
|
Control Group
n=18 Participants
Sham Control: Subjects will perform their regular denture cleaning routine.
|
|---|---|---|
|
Abrasion Assessment (Number)
|
0.98 number of abrasions
Standard Error .316
|
1.74 number of abrasions
Standard Error .288
|
PRIMARY outcome
Timeframe: Day 6The average size/area (in mm) of the total number of abrasions pre-food challenge
Outcome measures
| Measure |
Test Group
n=15 Participants
Treatment Gel: In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.
|
Control Group
n=18 Participants
Sham Control: Subjects will perform their regular denture cleaning routine.
|
|---|---|---|
|
Abrasion Assessment (Size)
|
2.67 mm
Standard Error 1.079
|
5.58 mm
Standard Error .981
|
PRIMARY outcome
Timeframe: Week 2The average size/area (in mm) of the total number of abrasions pre-food challenge
Outcome measures
| Measure |
Test Group
n=15 Participants
Treatment Gel: In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.
|
Control Group
n=18 Participants
Sham Control: Subjects will perform their regular denture cleaning routine.
|
|---|---|---|
|
Abrasion Assessment (Size)
|
3.18 mm
Standard Error .523
|
2.20 mm
Standard Error .476
|
PRIMARY outcome
Timeframe: Week 4The average size/area (in mm) of the total number of abrasions pre-food challenge
Outcome measures
| Measure |
Test Group
n=15 Participants
Treatment Gel: In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.
|
Control Group
n=18 Participants
Sham Control: Subjects will perform their regular denture cleaning routine.
|
|---|---|---|
|
Abrasion Assessment (Size)
|
2.15 mm
Standard Error .647
|
3.39 mm
Standard Error .588
|
PRIMARY outcome
Timeframe: Day 3The mucosal region under the denture was assessed with one score per arch (two total arches) each arch is scored ranging from 0(better) - 3(worse). The scores are then summed for a total score. The scale is measured as follows: 0 = pink firm tissue absent of redness and inflammation; 1 = mild redness or inflammation - slight change in color and little change in texture; 2 = moderate redness and/or inflammation - moderate glazing, redness, edema and hypertrophy 3 = severe redness and/or inflammation - marked redness and hypertrophy.
Outcome measures
| Measure |
Test Group
n=16 Participants
Treatment Gel: In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.
|
Control Group
n=20 Participants
Sham Control: Subjects will perform their regular denture cleaning routine.
|
|---|---|---|
|
Mucosal Assessment
|
.97 units on a scale
Standard Error .048
|
1.04 units on a scale
Standard Error .043
|
PRIMARY outcome
Timeframe: Day 6The mucosal region under the denture was assessed with one score per arch (two total arches) each arch is scored ranging from 0(better) - 3(worse). The scores are then summed for a total score. The scale is measured as follows: 0 = pink firm tissue absent of redness and inflammation; 1 = mild redness or inflammation - slight change in color and little change in texture; 2 = moderate redness and/or inflammation - moderate glazing, redness, edema and hypertrophy 3 = severe redness and/or inflammation - marked redness and hypertrophy.
Outcome measures
| Measure |
Test Group
n=15 Participants
Treatment Gel: In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.
|
Control Group
n=18 Participants
Sham Control: Subjects will perform their regular denture cleaning routine.
|
|---|---|---|
|
Mucosal Assessment
|
.77 units on a scale
Standard Error .049
|
1.05 units on a scale
Standard Error .044
|
PRIMARY outcome
Timeframe: Week 2The mucosal region under the denture was assessed with one score per arch (two total arches) each arch is scored ranging from 0(better) - 3(worse). The scores are then summed for a total score. The scale is measured as follows: 0 = pink firm tissue absent of redness and inflammation; 1 = mild redness or inflammation - slight change in color and little change in texture; 2 = moderate redness and/or inflammation - moderate glazing, redness, edema and hypertrophy 3 = severe redness and/or inflammation - marked redness and hypertrophy.
Outcome measures
| Measure |
Test Group
n=15 Participants
Treatment Gel: In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.
|
Control Group
n=18 Participants
Sham Control: Subjects will perform their regular denture cleaning routine.
|
|---|---|---|
|
Mucosal Assessment
|
.70 units on a scale
Standard Error .062
|
1.03 units on a scale
Standard Error .056
|
PRIMARY outcome
Timeframe: Week 4The mucosal region under the denture was assessed with one score per arch (two total arches) each arch is scored ranging from 0(better) - 3(worse). The scores are then summed for a total score. The scale is measured as follows: 0 = pink firm tissue absent of redness and inflammation; 1 = mild redness or inflammation - slight change in color and little change in texture; 2 = moderate redness and/or inflammation - moderate glazing, redness, edema and hypertrophy 3 = severe redness and/or inflammation - marked redness and hypertrophy.
Outcome measures
| Measure |
Test Group
n=15 Participants
Treatment Gel: In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.
|
Control Group
n=18 Participants
Sham Control: Subjects will perform their regular denture cleaning routine.
|
|---|---|---|
|
Mucosal Assessment
|
.60 units on a scale
Standard Error .062
|
1.06 units on a scale
Standard Error .056
|
Adverse Events
Test Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Group
n=18 participants at risk
Treatment Gel: In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.
|
Control Group
n=20 participants at risk
Sham Control: Subjects will perform their regular denture cleaning routine.
|
|---|---|---|
|
Gastrointestinal disorders
Mouth Ulceration
|
11.1%
2/18 • Number of events 4 • Adverse event data were collected for all four weeks of study duration.
|
0.00%
0/20 • Adverse event data were collected for all four weeks of study duration.
|
|
Gastrointestinal disorders
Desquamation Oral
|
0.00%
0/18 • Adverse event data were collected for all four weeks of study duration.
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected for all four weeks of study duration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI should disclose plans to sponsor prior to public release.
- Publication restrictions are in place
Restriction type: OTHER