Trial Outcomes & Findings for Preventing and Arresting Dental Root Surface Caries in Community-dwelling Older Adults (NCT NCT02360124)
NCT ID: NCT02360124
Last Updated: 2016-07-25
Results Overview
the number of new tooth root caries lesions, i.e. tooth roots that have changed from sound at baseline to decayed at the evaluation examination will be counted in the clinical examination
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
323 participants
Primary outcome timeframe
30 months
Results posted on
2016-07-25
Participant Flow
Participant milestones
| Measure |
Control
instructions on oral hygiene (OHI) tailored to the individual's condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.
Water as placebo: topical application of water as a placebo in the control arm
|
Silver Diammine Fluoride
the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.
silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces
|
Silver Diammine Fluoride and KI
the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.
silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces
|
|---|---|---|---|
|
Overall Study
STARTED
|
108
|
107
|
108
|
|
Overall Study
COMPLETED
|
80
|
95
|
82
|
|
Overall Study
NOT COMPLETED
|
28
|
12
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preventing and Arresting Dental Root Surface Caries in Community-dwelling Older Adults
Baseline characteristics by cohort
| Measure |
Control
n=108 Participants
instructions on oral hygiene (OHI) tailored to the individual's condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.
Water as placebo: topical application of water as a placebo in the control arm
|
Silver Diammine Fluoride
n=107 Participants
the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.
silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces
|
Silver Diammine Fluoride and KI
n=108 Participants
the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.
silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces
|
Total
n=323 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
85 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
279 Participants
n=4 Participants
|
|
Age, Continuous
|
71.1 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
72.4 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
72.7 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
72.1 years
STANDARD_DEVIATION 6.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
253 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
108 participants
n=5 Participants
|
107 participants
n=7 Participants
|
108 participants
n=5 Participants
|
323 participants
n=4 Participants
|
|
Region of Enrollment
China
|
108 participants
n=5 Participants
|
107 participants
n=7 Participants
|
108 participants
n=5 Participants
|
323 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 monthsthe number of new tooth root caries lesions, i.e. tooth roots that have changed from sound at baseline to decayed at the evaluation examination will be counted in the clinical examination
Outcome measures
| Measure |
Control
n=80 Participants
instructions on oral hygiene (OHI) tailored to the individual's condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.
Water as placebo: topical application of water as a placebo in the control arm
|
Silver Diammine Fluoride
n=95 Participants
the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.
silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces
|
Silver Diammine Fluoride and KI
n=82 Participants
the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.
silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces
|
|---|---|---|---|
|
Number of New Tooth Root Caries Lesions
|
1.1 new carious root surfaces
Standard Error 0.16
|
0.43 new carious root surfaces
Standard Error 0.09
|
0.56 new carious root surfaces
Standard Error 0.11
|
SECONDARY outcome
Timeframe: 30 monthsPopulation: The participants were the active root caries lesions found at baseline in each group.
the proportion of active tooth root caries lesions at baseline that has changed to inactive root caries lesions at the evaluation examination will be calculated. The calculation is to divide the number of caries lesions that have changed status from active to inactive (assessed in clinical examination) by the number of active caries lesions found at baseline
Outcome measures
| Measure |
Control
n=20 Participants
instructions on oral hygiene (OHI) tailored to the individual's condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.
Water as placebo: topical application of water as a placebo in the control arm
|
Silver Diammine Fluoride
n=40 Participants
the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.
silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces
|
Silver Diammine Fluoride and KI
n=40 Participants
the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.
silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces
|
|---|---|---|---|
|
Proportion of Inactive Root Caries Lesions
|
45.0 percentage of inactive root caries
|
90.0 percentage of inactive root caries
|
92.5 percentage of inactive root caries
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Silver Diammine Fluoride
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Silver Diammine Fluoride and KI
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