- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03423797
The Caries-arresting Effect of Incorporating fTCP to NaF Varnish Applied Following AgNO3 in Preschool Children
Effectiveness of Biannual Application of Silver Nitrate Solution Followed by Sodium Fluoride Varnish With or Without Functionalized Tricalcium Phosphate in Arresting Caries in Preschool Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aim:The objective of this study is to compare the effectiveness of commercially available of 25% AgNO3 solution plus 5% NaF varnish and 25% AgNO3 solution plus 5% NaF varnish with fTCP when applied semi-annually over 30 months in arresting dentine caries of primary teeth among preschool children.
Methods: The extension of the Consolidated Standards of Reporting Trials 2010 Statement will be followed for this 30-month, randomised, double-blinded, equivalence clinical trial. Approximately 2,000 kindergarten children will be screened and at least 376 children with caries will be recruited. This sample size is sufficient for an appropriate statistical analysis. The children will be randomly allocated into 2 groups to treat their caries over a 30-month period: Group A - biannual application of a 25% AgNO3 solution followed by a 5% NaF varnish, and Group B - biannual application of a 25% AgNO3 solution followed by a 5% NaF varnish with functionalized tricalcium phosphate (fTCP).Clinical examinations will be conducted at 6-month intervals to assess whether the caries are arrested (primary outcome). Confounding factors such as oral hygiene habits will be collected through a parental questionnaire.
Possible results and implications: As the first of its kind, this study would help to determine whether AgNO3 followed by 5% NaF varnish with and without fTCP are equivalent in arresting dentine caries of primary teeth in preschool children when applied semi-annually.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Hong Kong, China
- The University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- have at least one tooth with cavitated dentine carious lesion
Exclusion Criteria:
- Children have severe forms of dental hypoplasia, under dental treatment or wearing orthodontic devices, have major systemic illness, and are on long-term medication.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: NaF without fTCP
25% AgNO3 solution followed by 5% NaF.
|
Dosage: 25% AgNO3 solution 7.9mg(Ag+)/0.05ml
(max dose), 5% NaF: 11.6mg (F-)/0.5ml
(max dose).
Other Names:
|
Experimental: NaF with fTCP
25% AgNO3 solution followed by 5% NaF with fTCP.
|
Dosage: 25% AgNO3 solution 7.9mg(Ag+)/0.05ml
(max dose), 5% NaF with fTCP: 11.6mg (F-)/0.5ml
(max dose).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The hardness of cavity on tooth by probing
Time Frame: The follow-up oral examinations will be conducted every 6 months for 30 months totally
|
The effectiveness of adjunctive application of 25% AgNO3 solution and 5% NaF varnish with or without fTCP is expected to be equivalent in arresting dentine caries of primary teeth.
|
The follow-up oral examinations will be conducted every 6 months for 30 months totally
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chun Hung Chu, Ph.D, The University of Hong Kong
Publications and helpful links
General Publications
- Chen KJ, Gao SS, Duangthip D, Lo ECM, Chu CH. Randomized Clinical Trial on Sodium Fluoride with Tricalcium Phosphate. J Dent Res. 2021 Jan;100(1):66-73. doi: 10.1177/0022034520952031. Epub 2020 Aug 31.
- Chen KJ, Gao SS, Duangthip D, Lo ECM, Chu CH. The caries-arresting effect of incorporating functionalized tricalcium phosphate into fluoride varnish applied following application of silver nitrate solution in preschool children: study protocol for a randomized, double-blind clinical trial. Trials. 2018 Jul 4;19(1):352. doi: 10.1186/s13063-018-2741-1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW 17-176
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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