Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries

April 28, 2021 updated by: The University of Hong Kong

A Randomized Controlled Trial on the Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries

Nearly half of the 12-year-old children in China have dental caries (tooth decay) and most of the lesions are in the fissures of the first permanent molars. This study aims to investigate the effectiveness of three methods in preventing fissure caries in permanent teeth in Chinese children, namely resin fissure sealant, sodium fluoride varnish, and silver diamine fluoride solution. The cost-effectiveness of these methods will also be compared. About 400 children, aged 8 to 9 years, will be recruited. Clinical examination of the children will be conducted in school using portable dental lights and instruments to identify teeth that need caries prevention. The children will be randomly allocated to one of the three test or the control groups. Treatments will be provided in the study primary schools according to standard clinical protocols. Follow-up examinations will be carried out every six months for 30 months to assess whether the preventive methods are successful, i.e. no dental caries develops in the treated teeth. The findings of this study will be of great value to dentists and public health authorities in deciding on the most appropriate dental caries prevention programme for school children in China and other developing countries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

502

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

  • China
      • Hong Kong, China
        • 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

5 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • school children in good general health
  • have at least one permanent first molars that has deep occlusal fissures, or fissures with signs of early caries

Exclusion Criteria:

  • children with major systemic disease or taking long-term medications
  • not cooperative or refuse dental treatments

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fissure sealant
single placement of resin fissure sealant on tooth surface
Other: placement of fissure sealant
placement of resin-based fissure sealant at baseline without replacement
Experimental: fluoride varnish
application of a 5% sodium fluoride varnish every 6 months
Other: fluoride varnish
topical applications of a 5% sodium fluoride (NaF) varnish onto tooth surface every 6 months
Experimental: SDF solution
application of a 38% silver diamine fluoride solution onto tooth surface every year
Other: silver fluoride
topical applications of a 38% silver diamine fluoride (SDF) solution onto tooth surface every year
Placebo Comparator: control
application of water onto tooth surface every year
Other: placebo control
application of water onto tooth surface every year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dental caries
Time Frame: 3 years
tooth decay appearing as a cavity on tooth surface
3 years

Collaborators and Investigators

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

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Edward CM Lo, PhD, 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

December 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 23, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (Estimate)

October 5, 2011

Study Record Updates

Last Update Posted (Actual)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW06-402T/1427

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.

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