Dental CariesPhase 2GIFVTNCT01129440
Glass Ionomer Sealant and Fluoride Varnish Study to Prevent Early Childhood Caries
A Phase 2 study testing Fluoride Varnish and Glass Ionomer Sealant in people with Dental Caries, run by University of California, San Francisco at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 2 to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Fluoride Varnish and Glass Ionomer Sealant
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 597 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Mar 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
San Ysidro Health Center
San Ysidro, California, 92173
About this study
Official title: Glass Ionomer Sealant and Fluoride Varnish Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Dental Caries
- Being tested
- Fluoride Varnish, Glass Ionomer Sealant
- Keywords
- Children, Fluoride varnish, Glass ionomer sealant, Prevention
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride VarnishDevice
Also called 3M ESPE CavityShield® single-dose fluoride varnish units
Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
Glass Ionomer SealantDevice
Also called GC Fuji TRIAGE CAPSULE and its conditioner
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.
| Study group | Role | What they receive |
|---|---|---|
| Fluoride Varnish | Active comparator | Topical fluoride varnish (FV) applications every 6 months Receives: Device: Fluoride Varnish |
| 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 Receives: Device: Fluoride Varnish; Device: Glass Ionomer Sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Assessed every 12 months (plus or minus 1 month); Month 36 reported
Secondary outcomes (4)
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.
Measured: Assessed every 12 months (plus or minus 1 month); Month 36 reported
Salivary Fluoride Level
Relative changes in salivary fluoride levels pre- and post-treatment will be measured from a subsample of participating children
Measured: 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
Measured: 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.
Measured: every 6 months; up to 7 days after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startJun 2011
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Francisco Ramos-Gomez, DDS, MS, MPH, Principal investigator, University of California, Los AngelesStuart Gansky, DrPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129440
- Sponsor's protocol ID
- NIDCR 09-014-E
- Other IDs
- U54DE019285
- Acronym
- GIFVT
- Status last verified
- Feb 2020
- First submitted
- 21 May 2010
- Last updated
- 4 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: UCSF DataShare (http://datashare.ucsf.edu) is no longer functional. The Data Dryad repository (https://datadryad.org) will be utilized instead.
Publications
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.
PubMed 28207379Tiwari 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.
PubMed 25101490Garcia 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.
PubMed 27759164Albino 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.
PubMed 28526003
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glass Ionomer Sealant and Fluoride Varnish Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01129440
- Acronym / sponsor ID
- GIFVT / NIDCR 09-014-E
- Conditions
- Dental Caries
- Keywords
- Children, Fluoride varnish, Glass ionomer sealant, Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 597 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Jun 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Posted 19 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoride Varnish | Active comparator | Device: Fluoride VarnishTopical fluoride varnish (FV) applications every 6 months |
| FV + Glass Ionomer Sealants | Experimental | Device: Fluoride Varnish, Device: Glass Ionomer SealantTopical fluoride varnish (FV) applications every 6 months, and fluoride-releasing glass ionomer sealants (GIS) placed on primary molars at baseline and annually, as needed |
Who may qualify
- Ages
- 2 to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoride VarnishAlso: 3M ESPE CavityShield® single-dose fluoride varnish unitsTopical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months. | Device | FV + Glass Ionomer Sealants, Fluoride Varnish |
| Glass Ionomer SealantAlso: GC Fuji TRIAGE CAPSULE and its conditionerFluoroaluminosilicate 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. | Device | FV + Glass Ionomer Sealants |
Primary outcome
Caries Incidence
Time frame: 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
Time frame: 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
4 secondary outcomes
Caries Patterns
Time frame: Assessed every 12 months (plus or minus 1 month); Month 36 reported
Salivary Fluoride Level
Time frame: Every 6 months (plus minus 1 month); Month 30 reported
Retention of Glass Ionomer Sealants
Time frame: Assessed every at 12 months and 24 months (plus minus 1 month); Month 24 reported
Adverse Event
Time frame: every 6 months; up to 7 days after application
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28207379Garcia 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.
- Results publication: PubMed 25101490Tiwari 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.
- Results publication: PubMed 27759164Garcia 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.
- Derived from this study: PubMed 28526003Albino 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Ramos-Gomez, DDS, MS, MPH principal investigator
University of California, Los Angeles
Stuart Gansky, DrPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluoride Varnish and Glass Ionomer Sealant in people with Dental Caries, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries Incidence (time frame: Assessed every 12 months (plus or minus 1 month); Month 36 reported). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01129440, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.