Arresting Active Dental Caries in Preschool Children by Topical Fluorides
Primary Purpose
Dental Caries
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SDF solution
NaF varnish
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries
Eligibility Criteria
Inclusion Criteria:
- Generally healthy children who have at least one tooth with untreated caries into dentine
Exclusion Criteria:
- Children who have major systemic diseases or on long-term medication, are uncooperative or refuse the treatment will be excluded.
Sites / Locations
- The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
SDF regular
SDF intensive
NaF varnish
Arm Description
3 applications of a 30% SDF solution will be applied onto the surface of dental caries lesions by a small brush regularly once a year
3 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
3 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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02426619
First Posted
November 17, 2014
Last Updated
March 4, 2016
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT02426619
Brief Title
Arresting Active Dental Caries in Preschool Children by Topical Fluorides
Official Title
A Randomized Clinical Trial on the Use of Sodium Fluoride Varnish and Silver Diamine Fluoride Solution for Arresting Active Dental Caries in Preschool Children
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
Preschool children attending the first year of the kindergartens will be invited to join this study. An invitation letter will be sent to the parents explaining the purpose and procedures of this study. Parental consent will be sought. Generally healthy children who have at least one tooth with untreated caries into dentine will be invited to participate and they will be followed for 30 months.
Dental clinical examination of the children will be conducted by a calibrated dentist in the kindergarten. Tooth and oral hygiene condition will be recorded. A parental questionnaire will be administered at baseline and at the 30-month follow-up visits regarding their children's socio-economic background and oral health related behaviours. The questionnaire will also assess parental satisfaction with their child's oral health and dental aesthetics.
All active dental caries lesions of the participant children will be treated if possible. The children will be categorized as having a high or a low caries rate. They will then be allocated by a stratified randomization method to one of the three study groups:
Group A - 3 applications of a 30% SDF solution at yearly interval Group B - 3 applications of a 30% SDF solution at weekly interval Group C - 3 applications of a 5% NaF varnish at weekly interval
A dental operator who is not involved in the examination of the child will apply the fluoride agents. Follow-up oral examinations will be conducted every 6 months in the kindergartens for 30 months. The status of the treated teeth and any possible side/adverse effects will be recorded in the follow-up examinations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
371 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SDF regular
Arm Type
Experimental
Arm Description
3 applications of a 30% SDF solution will be applied onto the surface of dental caries lesions by a small brush regularly once a year
Arm Title
SDF intensive
Arm Type
Experimental
Arm Description
3 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
Arm Title
NaF varnish
Arm Type
Active Comparator
Arm Description
3 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
Intervention Type
Device
Intervention Name(s)
SDF solution
Other Intervention Name(s)
silver diammine fluoride solution
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
NaF varnish
Other Intervention Name(s)
sodium fluoride varnish
Intervention Description
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
Primary Outcome Measure Information:
Title
change in hardness of dental caries lesion
Description
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
Time Frame
baseline and 30 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Generally healthy children who have at least one tooth with untreated caries into dentine
Exclusion Criteria:
Children who have major systemic diseases or on long-term medication, are uncooperative or refuse the treatment will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward CM Lo, BDS, PhD
Organizational Affiliation
Faculty of Dentistry, University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Arresting Active Dental Caries in Preschool Children by Topical Fluorides
We'll reach out to this number within 24 hrs