Trial Outcomes & Findings for Comparative Effectiveness of Treatments to Prevent Dental Caries (NCT NCT03448107)
NCT ID: NCT03448107
Last Updated: 2025-02-26
Results Overview
For any participants with untreated dental caries on teeth at baseline treated with SDF/FV or Glass ionomer atraumatic restorative treatment (ART)/FV to arrest (control) the infection, what is the proportion of participants that stayed arrested
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3345 participants
Primary outcome timeframe
Two years
Results posted on
2025-02-26
Participant Flow
Unit of analysis: Schools
Participant milestones
| Measure |
Simple Prevention
One drop (0.05 ml) of silver diamine fluoride (Advantage ArrestTM) solution at 38% concentration (2.24 F-ion mg/dose) will be dispensed per child. Posterior tooth surfaces to be treated will be dried, after which the SDF will be applied with a micro-brush to all asymptomatic carious lesions and to all pits and fissures on bicuspids and molar teeth for thirty seconds. Fluoride varnishes (5% NaF) will then be applied to all teeth.
Dosage frequency will be twice-yearly.
Silver Diamine Fluoride: Silver diamine fluoride (SDF)
Fluoride Varnishes: Fluoride varnish (FV)
|
Complex Prevention
Pits and fissures on all bicuspids and molar teeth will be sealed with glass ionomer sealants (GC Fuji IX). Glass ionomer sealants (interim therapeutic restorations/atraumatic restorations) will also be placed on all frank asymptomatic carious lesions. Fluoride varnishes (5% NaF) will then be applied to all teeth.
Dosage frequency will be twice-yearly.
Fluoride Varnishes: Fluoride varnish (FV)
Glass Ionomer: Glass Ionomer Sealants (GC Fuji IX)
|
|---|---|---|
|
Overall Study
STARTED
|
1558 17
|
1787 18
|
|
Overall Study
COMPLETED
|
1329 17
|
1529 18
|
|
Overall Study
NOT COMPLETED
|
229 0
|
258 0
|
Reasons for withdrawal
| Measure |
Simple Prevention
One drop (0.05 ml) of silver diamine fluoride (Advantage ArrestTM) solution at 38% concentration (2.24 F-ion mg/dose) will be dispensed per child. Posterior tooth surfaces to be treated will be dried, after which the SDF will be applied with a micro-brush to all asymptomatic carious lesions and to all pits and fissures on bicuspids and molar teeth for thirty seconds. Fluoride varnishes (5% NaF) will then be applied to all teeth.
Dosage frequency will be twice-yearly.
Silver Diamine Fluoride: Silver diamine fluoride (SDF)
Fluoride Varnishes: Fluoride varnish (FV)
|
Complex Prevention
Pits and fissures on all bicuspids and molar teeth will be sealed with glass ionomer sealants (GC Fuji IX). Glass ionomer sealants (interim therapeutic restorations/atraumatic restorations) will also be placed on all frank asymptomatic carious lesions. Fluoride varnishes (5% NaF) will then be applied to all teeth.
Dosage frequency will be twice-yearly.
Fluoride Varnishes: Fluoride varnish (FV)
Glass Ionomer: Glass Ionomer Sealants (GC Fuji IX)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
229
|
258
|
Baseline Characteristics
Comparative Effectiveness of Treatments to Prevent Dental Caries
Baseline characteristics by cohort
| Measure |
Simple Prevention
n=1558 Participants
One drop (0.05 ml) of silver diamine fluoride (Advantage ArrestTM) solution at 38% concentration (2.24 F-ion mg/dose) will be dispensed per child. Posterior tooth surfaces to be treated will be dried, after which the SDF will be applied with a micro-brush to all asymptomatic carious lesions and to all pits and fissures on bicuspids and molar teeth for thirty seconds. Fluoride varnishes (5% NaF) will then be applied to all teeth.
Dosage frequency will be twice-yearly.
Silver Diamine Fluoride: Silver diamine fluoride (SDF)
Fluoride Varnishes: Fluoride varnish (FV)
|
Complex Prevention
n=1787 Participants
Pits and fissures on all bicuspids and molar teeth will be sealed with glass ionomer sealants (GC Fuji IX). Glass ionomer sealants (interim therapeutic restorations/atraumatic restorations) will also be placed on all frank asymptomatic carious lesions. Fluoride varnishes (5% NaF) will then be applied to all teeth.
Dosage frequency will be twice-yearly.
Fluoride Varnishes: Fluoride varnish (FV)
Glass Ionomer: Glass Ionomer Sealants (GC Fuji IX)
|
Total
n=3345 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
774 Participants
n=5 Participants
|
979 Participants
n=7 Participants
|
1753 Participants
n=5 Participants
|
|
Age, Continuous
|
7.0 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
7.3 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
7.2 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
784 Participants
n=5 Participants
|
808 Participants
n=7 Participants
|
1592 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
13 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
346 Participants
n=5 Participants
|
522 Participants
n=7 Participants
|
868 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unreported
|
1162 Participants
n=5 Participants
|
1191 Participants
n=7 Participants
|
2353 Participants
n=5 Participants
|
|
Baseline untreated decay
|
221 Participants
n=5 Participants
|
276 Participants
n=7 Participants
|
497 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Two yearsPopulation: The analysis population are those participants who completed the study and had dental caries at baseline. This population is a subset of the full study population.
For any participants with untreated dental caries on teeth at baseline treated with SDF/FV or Glass ionomer atraumatic restorative treatment (ART)/FV to arrest (control) the infection, what is the proportion of participants that stayed arrested
Outcome measures
| Measure |
Simple Prevention
n=115 Participants
One drop (0.05 ml) of silver diamine fluoride (Advantage ArrestTM) solution at 38% concentration (2.24 F-ion mg/dose) will be dispensed per child. Posterior tooth surfaces to be treated will be dried, after which the SDF will be applied with a micro-brush to all asymptomatic carious lesions and to all pits and fissures on bicuspids and molar teeth for thirty seconds. Fluoride varnishes (5% NaF) will then be applied to all teeth.
Dosage frequency will be twice-yearly.
Silver Diamine Fluoride: Silver diamine fluoride (SDF)
Fluoride Varnishes: Fluoride varnish (FV)
|
Complex Prevention
n=157 Participants
Pits and fissures on all bicuspids and molar teeth will be sealed with glass ionomer sealants (GC Fuji IX). Glass ionomer sealants (interim therapeutic restorations/atraumatic restorations) will also be placed on all frank asymptomatic carious lesions. Fluoride varnishes (5% NaF) will then be applied to all teeth.
Dosage frequency will be twice-yearly.
Fluoride Varnishes: Fluoride varnish (FV)
Glass Ionomer: Glass Ionomer Sealants (GC Fuji IX)
|
|---|---|---|
|
Number of Participants With Arrested Dental Caries, Assessed Using a Clinical Oral Examination
|
48 Participants
|
53 Participants
|
PRIMARY outcome
Timeframe: Five yearsPopulation: The analysis population includes the total number of teeth in each participant in each group. Thus, the overall number of units analyzed will be greater than the number in participant flow (participant flow reflects individuals participating in the study).
For teeth without carious lesions (sound teeth) treated with SDF/FV or Glass ionomer/FV, how many teeth developed caries over the course of observation
Outcome measures
| Measure |
Simple Prevention
n=10860 Teeth
One drop (0.05 ml) of silver diamine fluoride (Advantage ArrestTM) solution at 38% concentration (2.24 F-ion mg/dose) will be dispensed per child. Posterior tooth surfaces to be treated will be dried, after which the SDF will be applied with a micro-brush to all asymptomatic carious lesions and to all pits and fissures on bicuspids and molar teeth for thirty seconds. Fluoride varnishes (5% NaF) will then be applied to all teeth.
Dosage frequency will be twice-yearly.
Silver Diamine Fluoride: Silver diamine fluoride (SDF)
Fluoride Varnishes: Fluoride varnish (FV)
|
Complex Prevention
n=10800 Teeth
Pits and fissures on all bicuspids and molar teeth will be sealed with glass ionomer sealants (GC Fuji IX). Glass ionomer sealants (interim therapeutic restorations/atraumatic restorations) will also be placed on all frank asymptomatic carious lesions. Fluoride varnishes (5% NaF) will then be applied to all teeth.
Dosage frequency will be twice-yearly.
Fluoride Varnishes: Fluoride varnish (FV)
Glass Ionomer: Glass Ionomer Sealants (GC Fuji IX)
|
|---|---|---|
|
Caries Prevention
|
210 teeth
|
179 teeth
|
Adverse Events
Simple Prevention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Complex Prevention
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