Silver Diamine Fluoride in Preventing Occlusal Caries in Primary Teeth

NCT05084001 | Unknown Phase 2

• 1 other identifier: UW20-028
• Study Type: interventional
• Target: 769
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries in Children

Outcome Measures

Primary Outcomes (1)

• dental caries increment in dmfs index

  development of decay into dentine to form cavity

  30 months

Study Arms (3)

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

EXPERIMENTAL

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

Drug: silver diamine fluoride

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

ACTIVE COMPARATOR

application of sodium fluoride varnish on occlusal surface of primary molars

Drug: sodium fluoride varnish

Tonic water

PLACEBO COMPARATOR

application of tonic water on occlusal surface of primary molars

Other: tonic water

Interventions

silver diamine fluoride DRUG

topical application of the agent on tooth surface

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

sodium fluoride varnish DRUG

topical application of the agent on tooth surface

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

tonic water OTHER

topical application of tonic water on tooth surface

Tonic water

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• be healthy
• have at least one caries-free (no cavitation) primary molar

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35604758 DERIVED

MeSH Terms

Interventions

silver diamine fluoride; Bifluorid 12

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: October 19, 2021
• Study Start: March 1, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: October 19, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)