Glass Ionomer Sealant Versus Fluoride Varnish on Occlusal Caries Prevention

November 12, 2019 updated by: Professor Cynthia Kar-Yung Yiu, The University of Hong Kong

Glass Ionomer Sealant Versus Fluoride Varnish Application to Prevent Occlusal Caries Among Preschool Children - a Randomized Controlled Trial

The current study compares the efficacy of glass ionomer fissure sealant versus topical application of 5% sodium fluoride varnish in prevention of occlusal caries among preschool children.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Topical fluoride varnish (TFV) with 5% sodium fluoride in its content has proven effective in preventing caries among children and adolescents. Its reduction in DMFT is well supported by Cochrane reviews and clinical trials. However, its effect in preventing pit and fissure caries in primary dentition has not been assessed.

Pit and fissure sealants have been a recommended procedure in preventing caries development in permanent molars. Multiple systematic reviews and clinical trials have concluded that fissure sealants are significantly more effective than topical fluoride varnishes in preventing occlusal caries in permanent molars. However, a recent Cochrane review suggested that there was still insufficient evidence to determine superiority of resin or glass ionomer fissure sealants over topical fluoride varnishes for occlusal caries prevention, due to the lack of reliable results and low quality of evidence.

Also, most studies were conducted on permanent first molars among school children, whom cooperation and moisture control can be easily achieved. However, application of fissure sealants, especially resin-based sealant, in very young children can be a technique-sensitive procedure. Compared with a mean treatment time of less than 3 minutes for varnish application, application of resin-based sealants required over 15 minutes. Moisture control is also of paramount importance for the retention and success of resin-based sealants, which may be difficult among young preschool children.

Glass-ionomer sealants can chemically bond to enamel and are more tolerable to inadequate moisture control. As its application requires less clinical steps, glass-ionomer sealant is comparatively more acceptable to younger patients and can be used in outreach settings with a large number of participants. The fluoride releasing ability is also beneficial in preventing caries especially at adjacent tooth surfaces. However, its retention rate is significantly lower than that of resin-based sealants, its success rate in preventing fissure caries in very young patients is still unknown.

Study Type

Interventional

Enrollment (Anticipated)

348

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Generally healthy children aged between 3-5 years with no remarkable medical history.

Exclusion Criteria:

  1. Children with the presence of caries of ICDAS code 3, 4, 5, or 6 on other primary teeth.
  2. Children who had received professional fluoride application in the past 6 months.
  3. Children with serious systemic disease or taking long term medication.
  4. Children who are uncooperative or refuse the treatment.
  5. Second primary molars that are (i) with caries in dentin indicated by ICDAS code 4, 5 or 6; (ii) partially erupted; (iii) with fillings and/or sealants; and (iv) hypoplastic or hypomineralized.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NaF varnish
Application of a 5% NaF varnish (Duraphat, Colgate-Palmolive Ltd, Waltrop, Germany) on the occlusal surfaces of primary second molars and all other teeth, every 3 months during the study period;
Procedure: 5% sodium fluoride varnish (NaF)
In the NaF varnish groups, 0.25mL (one drop) of the varnish is placed in a plastic dappen dish. A disposable microbrush is used to apply the varnish onto the second primary molars included in the study and all other teeth. The child is instructed not to eat or drink after the application of varnish for at least half an hour.
Other Names:
  • Topical fluoride varnish
  • Duraphat, Colgate-Palmolive Ltd, Waltrop, Germany
Experimental: GI sealant
Glass ionomer sealant (GC Fuji VII® (pink)) on all primary second molars included in the studies, with no further repair/replacement of the sealant
Procedure: Glass ionomer sealant (GIS)
Glass ionomer sealants (GIS) is applied using the finger pressure technique described in the WHO manual for atraumatic restorative treatment (ART) (Frencken et al.; 1997). The primary second molars are cleaned by applying GC cavity conditioner with micro-applicator for 10-15 seconds, then clean with wet cotton pellets for several times. The surface will be dried with cotton pellets. GIS (GC Fuji VII) is mixed in standardized proportion with an amalgamator, then applied to the occlusal surface and slightly overfilled. A gloved finger with petroleum jelly will be used to push and rub the materials into the pits and fissures, and removing the excess. GIS will be covered and protected by a layer of petroleum jelly (Vaseline ®).
Other Names:
  • GC Fuji VII® (pink)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caries increment
Time Frame: 24 months
Carious cavity development into dentin (ICDAS code 4, 5 and 6) on the occlusal surfaces of primary second molars over time.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sealant retention
Time Frame: 24 months
Retention of GIS on included primary second molar
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Department of Health and Human Services

Investigators

  • Principal Investigator: Cynthia Kar Yung Yiu, FHKAM,FCDSHK, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2018

Primary Completion (Anticipated)

August 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

November 12, 2019

First Submitted That Met QC Criteria

November 12, 2019

First Posted (Actual)

November 14, 2019

Study Record Updates

Last Update Posted (Actual)

November 14, 2019

Last Update Submitted That Met QC Criteria

November 12, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMRF project 16172221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Child

Clinical Trials on 5% sodium fluoride varnish (NaF)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe