Silver Diamine Fluoride in Preventing Occlusal Caries in Primary Teeth

October 6, 2021 updated by: The University of Hong Kong

Effectiveness of Silver Diamine Fluoride in Preventing Occlusal Caries in Primary Teeth of Preschool Children: a 30-month Randomized Clinical Trial

In Hong Kong, approximately half of the kindergarten children have dental caries (tooth decay) and the majority (>90%) of the decayed teeth were left untreated. There is a need to generate clinical evidence for designing an effective dental caries prevention programme for preschool children in Hong Kong. The objective of this study is to compare the effectiveness of 38% silver diamine fluoride (SDF), 5% sodium fluoride (NaF) varnish and placebo control in preventing dentine cavitated caries in primary molars in preschool children when applied semi-annually over 30 months. Around 770 preschool children attending Grade 1 in selected kindergartens will be invited to participate in this clinical trial. Only generally healthy children with written parental consent will be included. At baseline, clinical examination will be conducted in the kindergarten to assess the tooth and oral hygiene status of the included children. After the baseline examination, the children will be randomly assigned to one of the following three study groups and the occlusal (biting) surfaces of their primary molars will receive the corresponding interventions: Group A - semi-annual topical application of 38% SDF; Group B - semi-annual application of 5% NaF varnish; and Group C - semi-annual application of placebo control with tonic water. Clinical examination of the study teeth in the children will be conducted every 6 months after the baseline to assess the outcome of the intervention. The primary outcome is whether cavitated dentine caries lesion is found in the treated occlusal tooth surface. The null hypothesis tested is that there is no difference in the effectiveness of semi-annual application of 38% SDF and that of 5% NaF varnish versus placebo control in preventing dentin occlusal caries in primary molars of preschool children. The results of the proposed study will provide evidence to strengthen or refute the recommendation regarding the use of SDF for preventing occlusal caries in primary molars. The study findings will be valuable for guiding decision-making among dental practitioners and health policymakers on whether SDF should be complemented in a school-based caries prevention program.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

769

Phase

  • Phase 2
  • Phase 3

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
        • Recruiting
        • 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

2 years to 4 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. be healthy
  2. have at least one caries-free (no cavitation) primary molar

Exclusion Criteria:

  1. are uncooperative or refuse examination
  2. have major systemic disease
  3. present with either acute pain or infections or have gingival ulceration or stomatitis
  4. have known sensitivity to fluoride, silver or other heavy-metal ions
  5. are currently involved in any other research that may impact on the present study

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 38% SDF (Saforide, Toyo Seiyaku Kasei Co. Ltd., Japan)
application of silver diamine fluoride solution on occlusal surface of primary molars
Drug: silver diamine fluoride
topical application of the agent on tooth surface
ACTIVE_COMPARATOR: 5% NaF varnish (Duraphat, Colgate Palmolive, USA)
application of sodium fluoride varnish on occlusal surface of primary molars
Drug: sodium fluoride varnish
topical application of the agent on tooth surface
PLACEBO_COMPARATOR: Tonic water
application of tonic water on occlusal surface of primary molars
Other: tonic water
topical application of tonic water on tooth surface

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dental caries increment in dmfs index
Time Frame: 30 months
development of decay into dentine to form cavity
30 months

Collaborators and Investigators

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

Sponsor

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)

March 1, 2020

Primary Completion (ANTICIPATED)

July 31, 2023

Study Completion (ANTICIPATED)

July 31, 2023

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

October 6, 2021

First Posted (ACTUAL)

October 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2021

Last Update Submitted That Met QC Criteria

October 6, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW20-028

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.

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