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

Early Childhood Caries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02019160
• Other study ID #: chuch14
• Status: Completed
• Phase: Phase 3
• Start date: September 2014
• Est. completion date: June 2018

Study information

• Verified date: September 2019
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1070
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Early Childhood Caries

Intervention

Drug:
• 25% AgNO3 solution followed by 5% NaF varnish
Dosage of 4.4µg±1.4µg fluoride per use
• 38% SDF solution followed by placebo varnish
Dosage of 8.8µg±2.8µg fluoride per use

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, 

References & Publications (5)

Braga MM, Mendes FM, De Benedetto MS, Imparato JC. Effect of silver diammine fluoride on incipient caries lesions in erupting permanent first molars: a pilot study. J Dent Child (Chic). 2009 Jan-Apr;76(1):28-33. — View Citation

Chu CH, Fung DS, Lo EC. Dental caries status of preschool children in Hong Kong. Br Dent J. 1999 Dec 11;187(11):616-20; discussion 605. — View Citation

Chu CH, Lo EC, Lin HC. Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children. J Dent Res. 2002 Nov;81(11):767-70. — View Citation

Chu CH, Lo EC. A review of sodium fluoride varnish. Gen Dent. 2006 Jul-Aug;54(4):247-53. Review. — View Citation

Chu CH. Treatment of early childhood caries: a review and case report. Gen Dent. 2000 Mar-Apr;48(2):142-8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The hardness of cavity on tooth by probing	We expect that topical application of 25% AgNO3 solution followed by 5% NaF varnish and of 38% SDF solution can both effectively arrest ECC.	The follow-up oral examinations will be conducted every 6 months for 30 months totally