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

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT01129440
• Collaborator: National Institute of Dental and Craniofacial Research (NIDCR) (NIH)
• Enrollment: 597
• Location: 1
• Arms: 2
• Duration (Months): 57
• Patients Per Site Per Month: 10.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Device: Fluoride Varnish; Device: Glass Ionomer Sealant	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 597 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Glass Ionomer Sealant and Fluoride Varnish Randomized Clinical Trial
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Fluoride Varnish Topical fluoride varnish (FV) applications every 6 months	Device: Fluoride Varnish; Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.; Other Names: 3M ESPE CavityShield® single-dose fluoride varnish units
Experimental: 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	Device: Fluoride Varnish; Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.; Other Names: 3M ESPE CavityShield® single-dose fluoride varnish units ; Device: 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.; Other Names: GC Fuji TRIAGE CAPSULE and its conditioner

Outcome Measures

Primary Outcome Measures

1. 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)

2. 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 Outcome Measures

1. 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.

2. 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

3. 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

4. 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.

Other Outcome Measures

1. 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).

2. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 3 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Ysidro Health Center	San Ysidro	California	United States	92173

Sponsors and Collaborators

• University of California, San Francisco
• National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

• Principal Investigator: Francisco Ramos-Gomez, DDS, MS, MPH, University of California, Los Angeles
• Principal Investigator: Stuart Gansky, DrPH, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT01129440
• Other Study ID Numbers: NIDCR 09-014-E; U54DE019285
• First Posted: May 24, 2010
• Last Update Posted: Mar 4, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by University of California, San Francisco: Children; Fluoride varnish; Glass ionomer sealant; Prevention
• Additional relevant MeSH terms: Dental Caries; Fluorides; Fluorides, Topical

Study Results

Participant Flow

Arm/Group Title	Fluoride Varnish	FV + Glass Ionomer Sealants
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	297	300
12 Month Follow-up	249	256
24 Month Follow-up	239	258
COMPLETED	246	258
NOT COMPLETED	51	42

Baseline Characteristics

Arm/Group Title	Fluoride Varnish	FV + Glass Ionomer Sealants	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	297	300	597
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	3.4 (0.43)	3.4 (0.48)	3.4 (0.46)
Sex: Female, Male (Count of Participants)
Female	166 55.9%	154 51.3%	320 53.6%
Male	131 44.1%	146 48.7%	277 46.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	288 97%	284 94.7%	572 95.8%
Not Hispanic or Latino	9 3%	13 4.3%	22 3.7%
Unknown or Not Reported	0 0%	3 1%	3 0.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 0.3%	0 0%	1 0.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	6 2%	8 2.7%	14 2.3%
White	289 97.3%	285 95%	574 96.1%
More than one race	0 0%	3 1%	3 0.5%
Unknown or Not Reported	1 0.3%	4 1.3%	5 0.8%
Center (Count of Participants)
Center 1	148 49.8%	151 50.3%	299 50.1%
Center 2	149 50.2%	149 49.7%	298 49.9%

Outcome Measures

1. Primary Outcome

Title	Caries Incidence
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoride Varnish	FV + Glass Ionomer Sealants
Arm/Group Description	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.	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.
Measure Participants	246	258
Count of Participants [Participants]	137 46.1%	123 41%

2. Primary Outcome

Title	Caries Increment
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoride Varnish	FV + Glass Ionomer Sealants
Arm/Group Description	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.	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.
Measure Participants	246	258
Mean (95% Confidence Interval) [tooth surfaces]	4.9	4.1

3. Secondary Outcome

Title	Caries Patterns
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoride Varnish	FV + Glass Ionomer Sealants
Arm/Group Description	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.	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.
Measure Participants	246	258
Count of Participants [Participants]	117 39.4%	106 35.3%

4. Secondary Outcome

Title	Salivary Fluoride Level
Description	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

Outcome Measure Data

Analysis Population Description

Randomly selected subset with salivary fluoride measured

Arm/Group Title	Fluoride Varnish	FV + Glass Ionomer Sealants
Arm/Group Description	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.	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.
Measure Participants	35	34
Mean (Standard Deviation) [ppm]	0.072 (0.108)	0.128 (0.494)

5. Secondary Outcome

Title	Retention of Glass Ionomer Sealants
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FV + Glass Ionomer Sealants
Arm/Group Description	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.
Measure Participants	265
Count of Participants [Participants]	249 83.8%

6. Secondary Outcome

Title	Adverse Event
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoride Varnish	FV + Glass Ionomer Sealants
Arm/Group Description	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.	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.
Measure Participants	297	300
Count of Participants [Participants]	0 0%	1 0.3%

7. Other Pre-specified Outcome

Title	Effect Modification of Caries Incidence and Increment by Location
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Other Pre-specified Outcome

Title	Effect Modification of Caries Incidence and Increment by Baseline Frankl Child Behavior Score
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	36 months
Arm/Group Title	Fluoride Varnish		FV + Glass Ionomer Sealants
Arm/Group Description	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.		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.
All Cause Mortality
	Fluoride Varnish		FV + Glass Ionomer Sealants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/297 (0%)		0/300 (0%)
Serious Adverse Events
	Fluoride Varnish		FV + Glass Ionomer Sealants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/297 (0%)		0/300 (0%)
Other (Not Including Serious) Adverse Events
	Fluoride Varnish		FV + Glass Ionomer Sealants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/297 (0%)		1/300 (0.3%)
Infections and infestations
Viral infection	0/297 (0%)		1/300 (0.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.