Arresting Active Dental Caries in Preschool Children by Topical Fluorides
A Randomized Clinical Trial on the Use of Sodium Fluoride Varnish and Silver Diamine Fluoride Solution for Arresting Active Dental Caries in Preschool Children
1 other identifier
interventional
371
1 country
1
Brief Summary
This randomized clinical trial aims to compare the effectiveness of three topical fluoride application protocols, namely three applications of a 30% SDF solution at yearly or weekly interval and three applications of a 5% NaF varnish at weekly interval, in arresting dental caries in the primary teeth of preschool children over 30 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 27, 2015
CompletedMarch 7, 2016
March 1, 2016
2.6 years
November 17, 2014
March 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
change in hardness of dental caries lesion
change from a soft active dental caries lesion at baseline to a hardened arrested caries lesion upon gentle probing with a dental explorer at the evaluation is regarded as a positive treatment outcome
baseline and 30 months
Study Arms (3)
SDF regular
EXPERIMENTAL3 applications of a 30% SDF solution will be applied onto the surface of dental caries lesions by a small brush regularly once a year
SDF intensive
EXPERIMENTAL3 applications of a 30% SDF solution will be applied onto the surface of dental caries lesions by a small brush at weekly interval at baseline
NaF varnish
ACTIVE COMPARATOR3 applications of a 5% NaF varnish will be applied onto the surface of dental caries lesions by a small brush at weekly interval at baseline
Interventions
around 1 mL of 30% silver diammine fluoride (SDF) solution is placed in a small disposable container and a small brush will be used to apply a very small quantity of the solution onto the surface of the dental caries lesion in the tooth
around 1 mL of 5% NaF (sodium fluoride) varnish is placed in a small disposable container and a small brush will be used to apply a very small quantity of the solution onto the surface of the dental caries lesion in the tooth
Eligibility Criteria
You may qualify if:
- Generally healthy children who have at least one tooth with untreated caries into dentine
You may not qualify if:
- Children who have major systemic diseases or on long-term medication, are uncooperative or refuse the treatment will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Hong Kong
Hong Kong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward CM Lo, BDS, PhD
Faculty of Dentistry, University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2014
First Posted
April 27, 2015
Study Start
September 1, 2012
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
March 7, 2016
Record last verified: 2016-03