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Effectiveness of Dental Caries Arrest Treatment in Primary Teeth Using AgNO3 Followed by NaF Varnish

NCT02019160 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1070

Last updated 2019-09-26

No results posted yet for this study

Summary

* Aim: This randomised controlled trial will systematically compare the efficacy of a 25% AgNO3 solution followed by 5% NaF varnish with that of a 38% SDF solution in arresting caries teeth among preschool children when applied at half-yearly intervals over a 30-month period.
* Method: The extension of the Consolidated Standards of Reporting Trials 2010 Statement will be followed for this 30-month, randomised, double-blinded, non-inferiority clinical trial. Approximately 2,400 kindergarten children will be screened and at least 826 children with caries will be recruited. This sample size is sufficient for an appropriate statistical analysis (power at 90% \[β=0.10\] with a 2-sided type-I error of α=0.05), allowing for a 18% drop-out rate. 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 38% SDF solution followed by a placebo varnish.Clinical examinations will be conducted at 6-month intervals to assess whether the caries are arrested. Information on 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 NaF is at least as effective as SDF in arresting childhood caries. If so, because 25% AgNO3 and 5% NaF contain less silver and fluoride, respectively, than 38% SDF, their use would be more favourable than SDF in young children.

Conditions

  • Early Childhood Caries

Interventions

DRUG

25% AgNO3 solution followed by 5% NaF varnish

Dosage of 4.4μg±1.4μg fluoride per use

DRUG

38% SDF solution followed by placebo varnish

Dosage of 8.8μg±2.8μg fluoride per use

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Chun Hung Chu · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02019160 on ClinicalTrials.gov