Effectiveness of Dental Caries Arrest Treatment in Primary Teeth Using AgNO3 Followed by NaF Varnish
|ClinicalTrials.gov Identifier: NCT02019160|
Recruitment Status : Unknown
Verified May 2017 by Dr. Chun-Hung Chu, The University of Hong Kong.
Recruitment status was: Active, not recruiting
First Posted : December 24, 2013
Last Update Posted : May 2, 2017
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Early Childhood Caries||Drug: 25% AgNO3 solution followed by 5% NaF varnish Drug: 38% SDF solution followed by placebo varnish||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1070 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 in Arresting Early Childhood Caries in Preschool Children: a 30-month, Randomised, Double-blind, Non-inferiority Trial|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Experimental: Silver nitrate
Biannual application of 25% AgNO3 solution followed by 5% NaF varnish.
Drug: 25% AgNO3 solution followed by 5% NaF varnish
Dosage of 4.4μg±1.4μg fluoride per use
Active Comparator: Silver diamine fluoride
Biannual application of 38% SDF solution followed by placebo varnish.
Drug: 38% SDF solution followed by placebo varnish
Dosage of 8.8μg±2.8μg fluoride per use
Other Name: silver diamine fluoride
- 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 ]We expect that topical application of 25% AgNO3 solution followed by 5% NaF varnish and of 38% SDF solution can both effectively arrest ECC.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02019160
|The University of Hong Kong|
|Hong Kong, China|
|Principal Investigator:||Chun Hung Chu||The University of Hong Kong|