Trial Outcomes & Findings for Glass Ionomer Sealant and Fluoride Varnish Study to Prevent Early Childhood Caries (NCT NCT01129440)
NCT ID: NCT01129440
Last Updated: 2020-03-04
Results Overview
Caries incidence by 36 months measured by whether the change in the number of decayed, missing, or filled primary tooth surfaces (dmfs) index increased from baseline (ie. change in dmfs \>0)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
597 participants
Primary outcome timeframe
Assessed every 12 months (plus or minus 1 month); Month 36 reported
Results posted on
2020-03-04
Participant Flow
Participant milestones
| Measure |
Fluoride Varnish
Topical fluoride varnish (FV) applications every 6 months
Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
|
FV + Glass Ionomer Sealants
Topical fluoride varnish (FV) applications every 6 months, and fluoride-releasing glass ionomer sealants (GIS) placed on primary molars at baseline and annually, as needed
Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
Glass Ionomer Sealant: Fluoroaluminosilicate glass powder and polyacrylic acid liquid are mixed together in a capsule to form the glass ionomer sealant material.
After toothbrushing and conditioning dental surfaces with 20% polyacrylic acid for 10 seconds, pink-colored fluoride releasing glass ionomer dispensed from a capsule is applied to the occlusal (biting) surface of the molar.
|
|---|---|---|
|
Overall Study
STARTED
|
297
|
300
|
|
Overall Study
12 Month Follow-up
|
249
|
256
|
|
Overall Study
24 Month Follow-up
|
239
|
258
|
|
Overall Study
COMPLETED
|
246
|
258
|
|
Overall Study
NOT COMPLETED
|
51
|
42
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glass Ionomer Sealant and Fluoride Varnish Study to Prevent Early Childhood Caries
Baseline characteristics by cohort
| Measure |
Fluoride Varnish
n=297 Participants
Topical fluoride varnish (FV) applications every 6 months
Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
|
FV + Glass Ionomer Sealants
n=300 Participants
Topical fluoride varnish (FV) applications every 6 months, and fluoride-releasing glass ionomer sealants (GIS) placed on primary molars at baseline and annually, as needed
Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
Glass Ionomer Sealant: Fluoroaluminosilicate glass powder and polyacrylic acid liquid are mixed together in a capsule to form the glass ionomer sealant material.
After toothbrushing and conditioning dental surfaces with 20% polyacrylic acid for 10 seconds, pink-colored fluoride releasing glass ionomer dispensed from a capsule is applied to the occlusal (biting) surface of the molar.
|
Total
n=597 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3.4 years
STANDARD_DEVIATION 0.43 • n=5 Participants
|
3.4 years
STANDARD_DEVIATION 0.48 • n=7 Participants
|
3.4 years
STANDARD_DEVIATION 0.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
166 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
320 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
277 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
288 Participants
n=5 Participants
|
284 Participants
n=7 Participants
|
572 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
289 Participants
n=5 Participants
|
285 Participants
n=7 Participants
|
574 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Center
Center 1
|
148 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
299 Participants
n=5 Participants
|
|
Center
Center 2
|
149 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
298 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed every 12 months (plus or minus 1 month); Month 36 reportedCaries incidence by 36 months measured by whether the change in the number of decayed, missing, or filled primary tooth surfaces (dmfs) index increased from baseline (ie. change in dmfs \>0)
Outcome measures
| Measure |
Fluoride Varnish
n=246 Participants
Topical fluoride varnish (FV) applications every 6 months
Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
|
FV + Glass Ionomer Sealants
n=258 Participants
Topical fluoride varnish (FV) applications every 6 months, and fluoride-releasing glass ionomer sealants (GIS) placed on primary molars at baseline and annually, as needed
Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
Glass Ionomer Sealant: Fluoroaluminosilicate glass powder and polyacrylic acid liquid are mixed together in a capsule to form the glass ionomer sealant material.
After toothbrushing and conditioning dental surfaces with 20% polyacrylic acid for 10 seconds, pink-colored fluoride releasing glass ionomer dispensed from a capsule is applied to the occlusal (biting) surface of the molar.
|
|---|---|---|
|
Caries Incidence
|
137 Participants
|
123 Participants
|
PRIMARY outcome
Timeframe: Assessed every 12 months (plus or minus 1 month); Month 36 reportedCaries increment by 36 months measured by the amount of change in dmfs index from baseline
Outcome measures
| Measure |
Fluoride Varnish
n=246 Participants
Topical fluoride varnish (FV) applications every 6 months
Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
|
FV + Glass Ionomer Sealants
n=258 Participants
Topical fluoride varnish (FV) applications every 6 months, and fluoride-releasing glass ionomer sealants (GIS) placed on primary molars at baseline and annually, as needed
Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
Glass Ionomer Sealant: Fluoroaluminosilicate glass powder and polyacrylic acid liquid are mixed together in a capsule to form the glass ionomer sealant material.
After toothbrushing and conditioning dental surfaces with 20% polyacrylic acid for 10 seconds, pink-colored fluoride releasing glass ionomer dispensed from a capsule is applied to the occlusal (biting) surface of the molar.
|
|---|---|---|
|
Caries Increment
|
4.9 tooth surfaces
Interval 4.0 to 5.9
|
4.1 tooth surfaces
Interval 3.3 to 5.0
|
SECONDARY outcome
Timeframe: Assessed every 12 months (plus or minus 1 month); Month 36 reportedDetermine and compare caries patterns (maxillary incisor smooth surfaces, posterior occlusal surfaces) across study arms over time. Occlusal surface dmfs\>0 in baseline eligible molar teeth.
Outcome measures
| Measure |
Fluoride Varnish
n=246 Participants
Topical fluoride varnish (FV) applications every 6 months
Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
|
FV + Glass Ionomer Sealants
n=258 Participants
Topical fluoride varnish (FV) applications every 6 months, and fluoride-releasing glass ionomer sealants (GIS) placed on primary molars at baseline and annually, as needed
Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
Glass Ionomer Sealant: Fluoroaluminosilicate glass powder and polyacrylic acid liquid are mixed together in a capsule to form the glass ionomer sealant material.
After toothbrushing and conditioning dental surfaces with 20% polyacrylic acid for 10 seconds, pink-colored fluoride releasing glass ionomer dispensed from a capsule is applied to the occlusal (biting) surface of the molar.
|
|---|---|---|
|
Caries Patterns
|
117 Participants
|
106 Participants
|
SECONDARY outcome
Timeframe: Every 6 months (plus minus 1 month); Month 30 reportedPopulation: Randomly selected subset with salivary fluoride measured
Relative changes in salivary fluoride levels pre- and post-treatment will be measured from a subsample of participating children
Outcome measures
| Measure |
Fluoride Varnish
n=35 Participants
Topical fluoride varnish (FV) applications every 6 months
Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
|
FV + Glass Ionomer Sealants
n=34 Participants
Topical fluoride varnish (FV) applications every 6 months, and fluoride-releasing glass ionomer sealants (GIS) placed on primary molars at baseline and annually, as needed
Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
Glass Ionomer Sealant: Fluoroaluminosilicate glass powder and polyacrylic acid liquid are mixed together in a capsule to form the glass ionomer sealant material.
After toothbrushing and conditioning dental surfaces with 20% polyacrylic acid for 10 seconds, pink-colored fluoride releasing glass ionomer dispensed from a capsule is applied to the occlusal (biting) surface of the molar.
|
|---|---|---|
|
Salivary Fluoride Level
|
0.072 ppm
Standard Deviation 0.108
|
0.128 ppm
Standard Deviation 0.494
|
SECONDARY outcome
Timeframe: Assessed every at 12 months and 24 months (plus minus 1 month); Month 24 reportedRetention and maintenance of fluoride-releasing glass ionomer sealants will be recorded from a subset of children using an intraoral digital camera
Outcome measures
| Measure |
Fluoride Varnish
n=265 Participants
Topical fluoride varnish (FV) applications every 6 months
Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
|
FV + Glass Ionomer Sealants
Topical fluoride varnish (FV) applications every 6 months, and fluoride-releasing glass ionomer sealants (GIS) placed on primary molars at baseline and annually, as needed
Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
Glass Ionomer Sealant: Fluoroaluminosilicate glass powder and polyacrylic acid liquid are mixed together in a capsule to form the glass ionomer sealant material.
After toothbrushing and conditioning dental surfaces with 20% polyacrylic acid for 10 seconds, pink-colored fluoride releasing glass ionomer dispensed from a capsule is applied to the occlusal (biting) surface of the molar.
|
|---|---|---|
|
Retention of Glass Ionomer Sealants
|
249 Participants
|
—
|
SECONDARY outcome
Timeframe: every 6 months; up to 7 days after applicationClinician mediated adverse event up to 7 days after fluoride varnish application, ascertained through follow-up telephone call 5-14 days after application.
Outcome measures
| Measure |
Fluoride Varnish
n=297 Participants
Topical fluoride varnish (FV) applications every 6 months
Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
|
FV + Glass Ionomer Sealants
n=300 Participants
Topical fluoride varnish (FV) applications every 6 months, and fluoride-releasing glass ionomer sealants (GIS) placed on primary molars at baseline and annually, as needed
Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
Glass Ionomer Sealant: Fluoroaluminosilicate glass powder and polyacrylic acid liquid are mixed together in a capsule to form the glass ionomer sealant material.
After toothbrushing and conditioning dental surfaces with 20% polyacrylic acid for 10 seconds, pink-colored fluoride releasing glass ionomer dispensed from a capsule is applied to the occlusal (biting) surface of the molar.
|
|---|---|---|
|
Adverse Event
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed every 12 months (plus minus 1 month)Caries increment measured by the amount of change in dmfs index from baseline separately by location and caries incidence measured by whether the change in dmfs index increased (ie. change in dmfs \>0) separately by location. Subgroup analyses will be performed with statistical models which have the location, the intervention group, and their interaction to assess possible effect modification (i.e. moderation).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed every 12 months (plus minus 1 month)Caries increment measured by the amount of change in dmfs index from baseline separately by baseline Frankl child behavior score and caries incidence measured by whether the change in dmfs index increased (ie. change in dmfs \>0) separately by Frankl score. Subgroup analyses will be performed with statistical models which have the baseline Frankl score, the intervention group, and their interaction to assess possible effect modification (i.e. moderation).
Outcome measures
Outcome data not reported
Adverse Events
Fluoride Varnish
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FV + Glass Ionomer Sealants
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluoride Varnish
n=297 participants at risk
Topical fluoride varnish (FV) applications every 6 months
Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
|
FV + Glass Ionomer Sealants
n=300 participants at risk
Topical fluoride varnish (FV) applications every 6 months, and fluoride-releasing glass ionomer sealants (GIS) placed on primary molars at baseline and annually, as needed
Fluoride Varnish: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
Glass Ionomer Sealant: Fluoroaluminosilicate glass powder and polyacrylic acid liquid are mixed together in a capsule to form the glass ionomer sealant material.
After toothbrushing and conditioning dental surfaces with 20% polyacrylic acid for 10 seconds, pink-colored fluoride releasing glass ionomer dispensed from a capsule is applied to the occlusal (biting) surface of the molar.
|
|---|---|---|
|
Infections and infestations
Viral infection
|
0.00%
0/297 • 36 months
|
0.33%
1/300 • 36 months
|
Additional Information
Dr. Stuart Gansky
University of California, San Francisco
Phone: 415-502-8094
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place