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

NCT03423797 | Completed Phase 3

• 1 other identifier: UW 17-176
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Early Childhood Caries

Keywords

silver nitrate; sodium fluoride; dental caries; equivalence trial

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

NaF without fTCP

ACTIVE COMPARATOR

25% AgNO3 solution followed by 5% NaF.

Drug: 25% AgNO3 solution followed by 5% NaF

NaF with fTCP

EXPERIMENTAL

25% AgNO3 solution followed by 5% NaF with fTCP.

Drug: 25% AgNO3 solution followed by 5% NaF with fTCP

Interventions

25% AgNO3 solution followed by 5% NaF DRUG

Dosage: 25% AgNO3 solution 7.9mg(Ag+)/0.05ml (max dose), 5% NaF: 11.6mg (F-)/0.5ml (max dose).

Also known as: 5% NaF without fTCP

NaF without fTCP

25% AgNO3 solution followed by 5% NaF with fTCP DRUG

Dosage: 25% AgNO3 solution 7.9mg(Ag+)/0.05ml (max dose), 5% NaF with fTCP: 11.6mg (F-)/0.5ml (max dose).

Also known as: 5% NaF with fTCP

NaF with fTCP

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• have at least one tooth with cavitated dentine carious lesion

You may not qualify if:

• Children have severe forms of dental hypoplasia, under dental treatment or wearing orthodontic devices, have major systemic illness, and are on long-term medication.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

Related Publications (2)

• 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.

  PMID: 32866050 DERIVED

• 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.

  PMID: 29973256 DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

4-fluoro-1-(1-(2-thienyl)cyclohexyl)piperidine

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Chun Hung Chu, Ph.D

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 6, 2018
• Study Start: September 1, 2017
• Primary Completion: May 1, 2020
• Study Completion: August 30, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

CN (1)