Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 33 for:    FLUORIDE ION AND NITRATE ION

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02019160
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Chun-Hung Chu, The University of Hong Kong

Tracking Information
First Submitted Date  ICMJE December 11, 2013
First Posted Date  ICMJE December 24, 2013
Last Update Posted Date September 26, 2019
Study Start Date  ICMJE September 2014
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02019160 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Dental Caries Arrest Treatment in Primary Teeth Using AgNO3 Followed by NaF Varnish
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Early Childhood Caries
Intervention  ICMJE
  • Drug: 25% AgNO3 solution followed by 5% NaF varnish
    Dosage of 4.4μg±1.4μg fluoride per use
    Other Names:
    • silver nitrate
    • sodium fluoride
  • Drug: 38% SDF solution followed by placebo varnish
    Dosage of 8.8μg±2.8μg fluoride per use
    Other Name: silver diamine fluoride
Study Arms  ICMJE
  • Experimental: Silver nitrate
    Biannual application of 25% AgNO3 solution followed by 5% NaF varnish.
    Intervention: Drug: 25% AgNO3 solution followed by 5% NaF varnish
  • Active Comparator: Silver diamine fluoride
    Biannual application of 38% SDF solution followed by placebo varnish.
    Intervention: Drug: 38% SDF solution followed by placebo varnish
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2017)
1070
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2013)
2040
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Kindergarteners who have joined our outreach dental service will be invited to join this study. Preschool children aged 3-4 years who have tooth decay and are attending the first year of kindergarten will be invited to join this study.

Exclusion Criteria:

  • Children who are uncooperative and difficult to manage, have major systemic diseases, or are on long-term medication will be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02019160
Other Study ID Numbers  ICMJE chuch14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chun-Hung Chu, The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chun Hung Chu The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP