The Caries-arresting Effect of Incorporating fTCP to NaF Varnish Applied Following AgNO3 in Preschool Children
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|ClinicalTrials.gov Identifier: NCT03423797|
Recruitment Status : Active, not recruiting
First Posted : February 6, 2018
Last Update Posted : November 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Early Childhood Caries||Drug: 25% AgNO3 solution followed by 5% NaF Drug: 25% AgNO3 solution followed by 5% NaF with fTCP||Phase 3|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||453 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||July 30, 2020|
Active Comparator: NaF without fTCP
25% AgNO3 solution followed by 5% NaF.
Drug: 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 Name: 5% NaF without fTCP
Experimental: NaF with fTCP
25% AgNO3 solution followed by 5% NaF with fTCP.
Drug: 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 Name: 5% NaF with fTCP
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423797
|The University of Hong Kong|
|Hong Kong, China|
|Principal Investigator:||Chun Hung Chu, Ph.D||The University of Hong Kong|