Trial Outcomes & Findings for Non-invasive Treatment of Root Caries in Older Adults (NCT NCT02647203)
NCT ID: NCT02647203
Last Updated: 2024-01-02
Results Overview
Using Nyvad's criteria for root caries lesions, activity will be assessed by a visual-tactile method.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
345 participants
Primary outcome timeframe
After 2 years of follow up
Results posted on
2024-01-02
Participant Flow
Participant milestones
| Measure |
High Fluoride Toothpaste
5,000 ppm fluoridated toothpaste, high concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)
Self-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.
|
Standard Fluoride Toothpaste
1,450 ppm fluoridated toothpaste, low concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)
Self-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.
|
|---|---|---|
|
12 Month Follow-up
STARTED
|
173
|
172
|
|
12 Month Follow-up
COMPLETED
|
148
|
149
|
|
12 Month Follow-up
NOT COMPLETED
|
25
|
23
|
|
24 Month Follow-up
STARTED
|
148
|
149
|
|
24 Month Follow-up
COMPLETED
|
142
|
138
|
|
24 Month Follow-up
NOT COMPLETED
|
6
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-invasive Treatment of Root Caries in Older Adults
Baseline characteristics by cohort
| Measure |
High Fluoride Toothpaste
n=173 Participants
5,000 ppm fluoridated toothpaste, high concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)
Self-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.
|
Standard Fluoride Toothpaste
n=172 Participants
1,450 ppm fluoridated toothpaste, low concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)
Self-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.
|
Total
n=345 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
173 Participants
n=99 Participants
|
172 Participants
n=107 Participants
|
345 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
131 Participants
n=99 Participants
|
127 Participants
n=107 Participants
|
258 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Socioeconomic status
Upper
|
64 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
|
Socioeconomic status
Lower
|
109 Participants
n=99 Participants
|
112 Participants
n=107 Participants
|
221 Participants
n=206 Participants
|
|
Education
Less or equal than 8 years
|
42 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Education
9 - 12 years
|
70 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
127 Participants
n=206 Participants
|
|
Education
More than 12 years
|
61 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
125 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: After 2 years of follow upPopulation: Independently-living older adults
Using Nyvad's criteria for root caries lesions, activity will be assessed by a visual-tactile method.
Outcome measures
| Measure |
High Fluoride Toothpaste
n=142 Participants
5,000 ppm fluoridated toothpaste, high concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)
Self-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.
|
Standard Fluoride Toothpaste
n=138 Participants
1,450 ppm fluoridated toothpaste, low concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)
Self-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.
|
|---|---|---|
|
Root Caries Activity
|
3.72 Percentage of active lesions (2-years)
Standard Deviation 12.32
|
40.52 Percentage of active lesions (2-years)
Standard Deviation 23.30
|
SECONDARY outcome
Timeframe: Data registered at 2 years of follow-upPopulation: Independently-living older adults
The impact on the quality of life of the therapy will be explored using the OHIP-14 Sp, validated by our group. In a scale ranging from 0 to 56 points, with 0-14 being good Oral Health-related quality of life and 15-56 poor Oral Health-related quality of life.
Outcome measures
| Measure |
High Fluoride Toothpaste
n=143 Participants
5,000 ppm fluoridated toothpaste, high concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)
Self-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.
|
Standard Fluoride Toothpaste
n=137 Participants
1,450 ppm fluoridated toothpaste, low concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)
Self-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.
|
|---|---|---|
|
Oral Health Related Quality of Life, Measured by the Oral Health Impact Profile (OHIP-14 Sp)
|
10.71 score on a scale
Standard Deviation 9.56
|
11.28 score on a scale
Standard Deviation 9.25
|
SECONDARY outcome
Timeframe: Baseline and 2-year follow upUnstimulated Salivary Flow, defined as Normal or Low Important: This outcome measure was originally considered. However, due to logistic issues, we did not assess it and no data is available.
Outcome measures
Outcome data not reported
Adverse Events
High Fluoride Toothpaste
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Fluoride Toothpaste
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place