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| ID | Type | Description | Link |
|---|---|---|---|
| U54DE019285 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoride Varnish | Active Comparator | Topical fluoride varnish (FV) applications every 6 months |
|
| FV + Glass Ionomer Sealants | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride Varnish | Device | Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Assessed every 12 months (plus or minus 1 month); Month 36 reported |
| Caries Increment | Caries increment by 36 months measured by the amount of change in dmfs index from baseline | Assessed every 12 months (plus or minus 1 month); Month 36 reported |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed every 12 months (plus or minus 1 month); Month 36 reported |
| Salivary Fluoride Level |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Ramos-Gomez, DDS, MS, MPH | University of California, Los Angeles | Principal Investigator |
| Stuart Gansky, DrPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Ysidro Health Center | San Ysidro | California | 92173 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28207379 | Result | Garcia RI, Gregorich SE, Ramos-Gomez F, Braun PA, Wilson A, Albino J, Tiwari T, Harper M, Batliner TS, Rasmussen M, Cheng NF, Santo W, Geltman PL, Henshaw M, Gansky SA. Absence of Fluoride Varnish-Related Adverse Events in Caries Prevention Trials in Young Children, United States. Prev Chronic Dis. 2017 Feb 16;14:E17. doi: 10.5888/pcd14.160372. | |
| 25101490 | Result | Tiwari T, Casciello A, Gansky SA, Henshaw M, Ramos-Gomez F, Rasmussen M, Garcia RI, Albino J, Batliner TS; Early Childhood Caries Collaborating Centers. Recruitment for health disparities preventive intervention trials: the early childhood caries collaborating centers. Prev Chronic Dis. 2014 Aug 7;11:E133. doi: 10.5888/pcd11.140140. |
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UCSF DataShare (http://datashare.ucsf.edu) is no longer functional. The Data Dryad repository (https://datadryad.org) will be utilized instead.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | FV + Glass Ionomer Sealants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Count of Participants | Participants | Assessed every 12 months (plus or minus 1 month); Month 36 reported |
|
36 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral infection | Infections and infestations | Systematic Assessment | Fever that a physician diagnosed as a viral infection. Study team judged AE as unrelated to study intervention and DSMB concurred. Garcia et al. 2017, PMC5313125. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stuart Gansky | University of California, San Francisco | 415-502-8094 | stuart.gansky@ucsf.edu |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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|
| Glass Ionomer Sealant | Device | 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. |
|
|
Relative changes in salivary fluoride levels pre- and post-treatment will be measured from a subsample of participating children |
| Every 6 months (plus minus 1 month); Month 30 reported |
| 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 | Assessed every at 12 months and 24 months (plus minus 1 month); Month 24 reported |
| 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. | every 6 months; up to 7 days after application |
| Assessed every 12 months (plus minus 1 month) |
| 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). | Assessed every 12 months (plus minus 1 month) |
| 27759164 | Result | Garcia RI, Tiwari T, Ramos-Gomez F, Heaton B, Orozco M, Rasmussen M, Braun P, Henshaw M, Borrelli B, Albino J, Diamond C, Gebel C, Batliner TS, Barker JC, Gregorich S, Gansky SA. Retention strategies for health disparities preventive trials: findings from the Early Childhood Caries Collaborating Centers. J Public Health Dent. 2017 Dec;77(1):63-77. doi: 10.1111/jphd.12182. Epub 2016 Oct 19. |
| 28526003 | Derived | Albino J, Tiwari T, Gansky SA, Henshaw MM, Barker JC, Brega AG, Gregorich SE, Heaton B, Batliner TS, Borrelli B, Geltman P, Kressin NR, Weintraub JA, Finlayson TL, Garcia RI; Early Childhood Caries Collaborating Centers. The basic research factors questionnaire for studying early childhood caries. BMC Oral Health. 2017 May 19;17(1):83. doi: 10.1186/s12903-017-0374-5. |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Center | Count of Participants | Participants |
|
|
|
| Primary | Caries Increment | Caries increment by 36 months measured by the amount of change in dmfs index from baseline | Posted | Mean | 95% Confidence Interval | tooth surfaces | Assessed every 12 months (plus or minus 1 month); Month 36 reported |
|
|
|
| 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. | Posted | Count of Participants | Participants | Assessed every 12 months (plus or minus 1 month); Month 36 reported |
|
|
|
| Secondary | Salivary Fluoride Level | Relative changes in salivary fluoride levels pre- and post-treatment will be measured from a subsample of participating children | Randomly selected subset with salivary fluoride measured | Posted | Mean | Standard Deviation | ppm | Every 6 months (plus minus 1 month); Month 30 reported |
|
|
|
| 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 | Posted | Count of Participants | Participants | Assessed every at 12 months and 24 months (plus minus 1 month); Month 24 reported |
|
|
|
| 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. | Posted | Count of Participants | Participants | every 6 months; up to 7 days after application |
|
|
|
| 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). | Not Posted | Assessed every 12 months (plus minus 1 month) | Participants |
| 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). | Not Posted | Assessed every 12 months (plus minus 1 month) | Participants |
| 0 |
| 297 |
| 0 |
| 297 |
| 0 |
| 297 |
| EG001 | 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. | 0 | 300 | 0 | 300 | 1 | 300 |
|
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