Preventing Caries With Silver Diamine Fluoride

Dental Caries Clinical Trial

Official title:

Preventing Early Childhood Caries With Silver Diamine Fluoride - a 12-month Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04399369
• Other study ID #: 20200520
• Status: Completed
• Phase: Phase 2
• Start date: September 16, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: December 2022
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Early childhood caries (tooth decay, ECC) affected 55% 5-year-old Hong Kong children, and 70% of these children had gross destruction of the upper anterior teeth with negative long-term impacts on health and quality of life. The existing standard of care for prevention of ECC, topical application of 5% sodium fluoride (NaF) varnish, is inadequate. In Hong Kong and other parts of the world, 38% silver diamine fluoride (SDF) solution, applied topically to cavities, is used to arrest ECC. Work published by our research group suggests it likely also has a preventive effect of ECC. Moreover, SDF has been shown to be preventive in tooth decay in permanent teeth. Nevertheless, no pivotal clinical trial has been performed to support a change in usual practice.

Aim: This is a Phase II single-centre randomized, double-blind, active-controlled, parallel-group pragmatic trial with two arms to assess the effectiveness of 38% SDF and 5% NaF in preventing new caries lesions in primary anterior teeth. Methods: 688 three-year-old kindergarten children who are healthy will be recruited, stratified by school, and block randomized to receive either 38% SDF (treatment group) or 5% NaF (standard treatment group) therapy on primary upper anterior teeth. This sample size is sufficient for a superiority trial with power at 90%, allowing for a 15% dropout rate. The primary outcome is the number of sound tooth surfaces that become cavitated caries per child at 12-month follow-up. The secondary outcome is the number of carious tooth surfaces developed after baseline that become arrested at 12-month for each child. Dental examinations for the status of caries (active or arrested) will be conducted by the same calibrated examiner. The examiner, children and children's parents will be blind to treatment allocation. Parents will be surveyed to study the children's oral health-related behaviours and socioeconomic backgrounds, which will allow the adjustment for effect modification. Possible results and implications: If the results are as anticipated, it will help change the standard of care for caries prevention. If adopted in Hong Kong, SDF therapy will prevent 20,800 (13% of the 160,000) kindergarten children from having caries developed in their anterior teeth, thus reduce significantly the burden of ECC of the children and related stress of their family. Moreover, the results will be widely available and increase adoption of SDF in other countries to reduce the global burden of ECC among children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 688
• Est. completion date: April 30, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 4 Years

Eligibility

Inclusion Criteria:

• generally healthy, with parental consents

Exclusion Criteria:

• uncooperative and difficult to manage, have major systemic diseases such as porphyria, or are on long-term medication such as anti-epileptic drugs.

Related Conditions & MeSH terms

• Dental Caries

Intervention

Device:
• SDF
38% silver diamine fluoride solution
• NaF
5% sodium fluoride varnish

Locations

Country	Name	City	State
Hong Kong	Local kindergartens	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	caries prevention	the number of sound tooth surfaces that become cavitated caries per child	at 12-month follow-up