Glass Ionomer Sealant and Fluoride Varnish Study to Prevent Early Childhood Caries

Dental Caries Clinical Trial

— GIFVT  

Official title:

Glass Ionomer Sealant and Fluoride Varnish Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01129440
• Other study ID #: NIDCR 09-014-E
• Secondary ID: U54DE019285
• Status: Completed
• Phase: Phase 2
• Start date: June 2011
• Est. completion date: March 2016

Study information

• Verified date: February 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 597
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	San Ysidro Health Center	San Ysidro	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 Youn — View Citation

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 — View Citation

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 collabor — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	Assessed every 12 months (plus minus 1 month)
Other	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)
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)	Assessed every 12 months (plus or minus 1 month); Month 36 reported
Primary	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
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.	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	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	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.	every 6 months; up to 7 days after application