Dental Caries
Conditions
Keywords
Children, Fluoride varnish, Glass ionomer sealant, Prevention
Brief summary
The goal of this project is to conduct a community-based randomized clinical trial to compare the caries prevention efficacy of fluoride varnish applied every six months vs. fluoride varnish applied every six months and fluoride releasing glass ionomer sealants applied annually to the eligible occlusal surfaces of primary molars in 3-6-year-old children.
Detailed description
Community-based, stratified (by location) randomized clinical trial (RCT) to determine the relative efficacy of topically applied fluoride varnish (FV) applications alone vs FV with fluoride-releasing glass ionomer (GI) sealants on occlusal surfaces of primary molars in reducing the caries incidence and increment in 3-6 year old children. A parallel groups design RCT stratified by study site (one dental and one non-dental location) will be conducted among 596 initially 2.5- to 3-year-old children. Those eligible will be randomized to one of 2 groups (FV or GIS+FV) and followed for 36 months. The RCT will take place at two sites serving primarily underserved, minority and low-income populations in Southern California: 1) the dental facility of the San Ysidro Health Center (SYHC) located near the U.S.-Mexican Border serves mainly Latino immigrants, and 2) the Comprehensive Health Center - Ocean View (CHC-OV), in a non-dental setting in close proximity to its dental clinic, which serves Latinos and African Americans. Both sites are part of a consortium of community clinics (SYHC Inc) and are located 15 miles apart from each other. Annual study dental examinations will be performed by trained, calibrated, study dentists to determine caries (precavitated and cavitated) incidence and increment. Children identified as needing dental care will be referred for appropriate treatment.
Interventions
DEVICEFluoride Varnish
Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
DEVICEGlass 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.
Sponsors
National Institute of Dental and Craniofacial Research (NIDCR)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 3 Years
Healthy volunteers
Yes
Inclusion criteria
* Family resides in the South Bay or Central San Diego area * Parent/Guardian can consent in English or Spanish * Child has 1-8 caries-free primary molars (with no occlusal pre-cavitation and no restoration) * Child is cooperative and behaviorally suited for the clinical trial interventions * Child is a registered patient at San Ysidro Health Center Inc.
Exclusion criteria
* Any siblings of participants * Child with cavitated lesions * Child with a health condition, special need, or with a complicated factor that will prevent from completing the required number of visits during a 36-month follow-up period * Anything, that in the opinion of the investigator, would preclude the child from complying with the protocol or jeopardize the safety of the child while on the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caries Incidence | Assessed every 12 months (plus or minus 1 month); Month 36 reported | 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) |
| Caries Increment | Assessed every 12 months (plus or minus 1 month); Month 36 reported | Caries increment by 36 months measured by the amount of change in dmfs index from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Fluoride Level | Every 6 months (plus minus 1 month); Month 30 reported | Relative changes in salivary fluoride levels pre- and post-treatment will be measured from a subsample of participating children |
| Adverse Event | every 6 months; up to 7 days after application | Clinician mediated adverse event up to 7 days after fluoride varnish application, ascertained through follow-up telephone call 5-14 days after application. |
| Retention of Glass Ionomer Sealants | Assessed every at 12 months and 24 months (plus minus 1 month); Month 24 reported | Retention and maintenance of fluoride-releasing glass ionomer sealants will be recorded from a subset of children using an intraoral digital camera |
| Caries Patterns | Assessed every 12 months (plus or minus 1 month); Month 36 reported | Determine 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effect Modification of Caries Incidence and Increment by Location | 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). |
| Effect Modification of Caries Incidence and Increment by Baseline Frankl Child Behavior Score | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 297 |
| 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. | 300 |
| Total | 597 |
Baseline characteristics
| Characteristic | Total | Fluoride Varnish | FV + Glass Ionomer Sealants |
|---|---|---|---|
| Age, Continuous | 3.4 years STANDARD_DEVIATION 0.46 | 3.4 years STANDARD_DEVIATION 0.43 | 3.4 years STANDARD_DEVIATION 0.48 |
| Center Center 1 | 299 Participants | 148 Participants | 151 Participants |
| Center Center 2 | 298 Participants | 149 Participants | 149 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 572 Participants | 288 Participants | 284 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 9 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 574 Participants | 289 Participants | 285 Participants |
| Sex: Female, Male Female | 320 Participants | 166 Participants | 154 Participants |
| Sex: Female, Male Male | 277 Participants | 131 Participants | 146 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 297 | 0 / 300 |
| other Total, other adverse events | 0 / 297 | 1 / 300 |
| serious Total, serious adverse events | 0 / 297 | 0 / 300 |
Outcome results
Primary
Caries Incidence
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)
Time frame: Assessed every 12 months (plus or minus 1 month); Month 36 reported
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluoride Varnish | Caries Incidence | 137 Participants |
| FV + Glass Ionomer Sealants | Caries Incidence | 123 Participants |
Primary
Caries Increment
Caries increment by 36 months measured by the amount of change in dmfs index from baseline
Time frame: Assessed every 12 months (plus or minus 1 month); Month 36 reported
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Fluoride Varnish | Caries Increment | 4.9 tooth surfaces |
| FV + Glass Ionomer Sealants | Caries Increment | 4.1 tooth surfaces |
Secondary
Adverse Event
Clinician mediated adverse event up to 7 days after fluoride varnish application, ascertained through follow-up telephone call 5-14 days after application.
Time frame: every 6 months; up to 7 days after application
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluoride Varnish | Adverse Event | 0 Participants |
| FV + Glass Ionomer Sealants | Adverse Event | 1 Participants |
Secondary
Caries Patterns
Determine 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.
Time frame: Assessed every 12 months (plus or minus 1 month); Month 36 reported
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluoride Varnish | Caries Patterns | 117 Participants |
| FV + Glass Ionomer Sealants | Caries Patterns | 106 Participants |
Secondary
Retention of Glass Ionomer Sealants
Retention and maintenance of fluoride-releasing glass ionomer sealants will be recorded from a subset of children using an intraoral digital camera
Time frame: Assessed every at 12 months and 24 months (plus minus 1 month); Month 24 reported
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluoride Varnish | Retention of Glass Ionomer Sealants | 249 Participants |
Secondary
Salivary Fluoride Level
Relative changes in salivary fluoride levels pre- and post-treatment will be measured from a subsample of participating children
Time frame: Every 6 months (plus minus 1 month); Month 30 reported
Population: Randomly selected subset with salivary fluoride measured
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluoride Varnish | Salivary Fluoride Level | 0.072 ppm | Standard Deviation 0.108 |
| FV + Glass Ionomer Sealants | Salivary Fluoride Level | 0.128 ppm | Standard Deviation 0.494 |
Other Pre-specified
Effect Modification of Caries Incidence and Increment by Baseline Frankl Child Behavior Score
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).
Time frame: Assessed every 12 months (plus minus 1 month)
Other Pre-specified
Effect Modification of Caries Incidence and Increment by Location
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).
Time frame: Assessed every 12 months (plus minus 1 month)