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Silver Diamine Fluoride in Preventing Occlusal Caries in Primary Teeth

NCT ID: NCT05084001

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

769 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2023-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Caries in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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38% SDF (Saforide, Toyo Seiyaku Kasei Co. Ltd., Japan)

application of silver diamine fluoride solution on occlusal surface of primary molars

Group Type EXPERIMENTAL

silver diamine fluoride

Intervention Type DRUG

topical application of the agent on tooth surface

5% NaF varnish (Duraphat, Colgate Palmolive, USA)

application of sodium fluoride varnish on occlusal surface of primary molars

Group Type ACTIVE_COMPARATOR

sodium fluoride varnish

Intervention Type DRUG

topical application of the agent on tooth surface

Tonic water

application of tonic water on occlusal surface of primary molars

Group Type PLACEBO_COMPARATOR

tonic water

Intervention Type OTHER

topical application of tonic water on tooth surface

Interventions

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silver diamine fluoride

topical application of the agent on tooth surface

Intervention Type DRUG

sodium fluoride varnish

topical application of the agent on tooth surface

Intervention Type DRUG

tonic water

topical application of tonic water on tooth surface

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The University of Hong Kong

Hong Kong, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Edward Lo

Role: primary

[email protected]
852-28590292

References

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Duangthip D, He S, Gao SS, Chu CH, Lo ECM. Effectiveness of Silver Diamine Fluoride for Preventing Occlusal Caries in the Primary Teeth of Preschool Children: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 May 23;11(5):e35145. doi: 10.2196/35145.

Reference Type DERIVED
PMID: 35604758 (View on PubMed)

Other Identifiers

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UW20-028

Identifier Type: -

Identifier Source: org_study_id