The Caries-arresting Effect of Incorporating fTCP to NaF Varnish Applied Following AgNO3 in Preschool Children

Early Childhood Caries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03423797
• Other study ID #: UW 17-176
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2017
• Est. completion date: August 30, 2020

Study information

• Verified date: November 2020
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to compare the effectiveness 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. Half of Participants will receive topical application of 25% AgNO3 solution and 5% NaF varnish, while the other half will receive topical application of 25% AgNO3 solution and 5% NaF varnish with fTCP.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: August 30, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Early Childhood Caries

Intervention

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).
• 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).

Locations

Country	Name	City	State
China	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The hardness of cavity on tooth by probing	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