Silver Diamine Fluoride in Preventing Occlusal Caries in Primary Teeth
Primary Purpose
Dental Caries in Children
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
silver diamine fluoride
sodium fluoride varnish
tonic water
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries in Children
Eligibility Criteria
Inclusion Criteria:
- be healthy
- have at least one caries-free (no cavitation) primary molar
Exclusion Criteria:
- 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
Sites / Locations
- The University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
38% SDF (Saforide, Toyo Seiyaku Kasei Co. Ltd., Japan)
5% NaF varnish (Duraphat, Colgate Palmolive, USA)
Tonic water
Arm Description
application of silver diamine fluoride solution on occlusal surface of primary molars
application of sodium fluoride varnish on occlusal surface of primary molars
application of tonic water on occlusal surface of primary molars
Outcomes
Primary Outcome Measures
dental caries increment in dmfs index
development of decay into dentine to form cavity
Secondary Outcome Measures
Full Information
NCT ID
NCT05084001
First Posted
June 8, 2021
Last Updated
October 6, 2021
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05084001
Brief Title
Silver Diamine Fluoride in Preventing Occlusal Caries in Primary Teeth
Official Title
Effectiveness of Silver Diamine Fluoride in Preventing Occlusal Caries in Primary Teeth of Preschool Children: a 30-month Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
769 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
38% SDF (Saforide, Toyo Seiyaku Kasei Co. Ltd., Japan)
Arm Type
Experimental
Arm Description
application of silver diamine fluoride solution on occlusal surface of primary molars
Arm Title
5% NaF varnish (Duraphat, Colgate Palmolive, USA)
Arm Type
Active Comparator
Arm Description
application of sodium fluoride varnish on occlusal surface of primary molars
Arm Title
Tonic water
Arm Type
Placebo Comparator
Arm Description
application of tonic water on occlusal surface of primary molars
Intervention Type
Drug
Intervention Name(s)
silver diamine fluoride
Intervention Description
topical application of the agent on tooth surface
Intervention Type
Drug
Intervention Name(s)
sodium fluoride varnish
Intervention Description
topical application of the agent on tooth surface
Intervention Type
Other
Intervention Name(s)
tonic water
Intervention Description
topical application of tonic water on tooth surface
Primary Outcome Measure Information:
Title
dental caries increment in dmfs index
Description
development of decay into dentine to form cavity
Time Frame
30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
be healthy
have at least one caries-free (no cavitation) primary molar
Exclusion Criteria:
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
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Lo
Phone
852-28590292
Email
edward-lo@hku.hk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35604758
Citation
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.
Results Reference
derived
Learn more about this trial
Silver Diamine Fluoride in Preventing Occlusal Caries in Primary Teeth
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