Clinical trial NCT02019160: Effectiveness of Dental Caries Arrest Treatment in Primary Teeth Using AgNO3 Followed by NaF Varnish
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Early Childhood Caries
Keywords: silver nitrate
sodium fluoride
silver diamine fluoride
caries
non-inferiority trial
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 1070
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The hardness of cavity on tooth by probing
timeFrame: The follow-up oral examinations will be conducted every 6 months for 30 months totally
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Chun Hung Chu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1038/sj.bdj.4800347.
citation: Chu CH. Treatment of early childhood caries: a review and case report. Gen Dent. 2000 Mar-Apr;48(2):142-8.
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. doi: 10.1177/0810767.
citation: Chu CH, Lo EC. A review of sodium fluoride varnish. Gen Dent. 2006 Jul-Aug;54(4):247-53.
citation: Gao SS, Duangthip D, Wong MCM, Lo ECM, Chu CH. Randomized Trial of Silver Nitrate with Sodium Fluoride for Caries Arrest. JDR Clin Trans Res. 2019 Apr;4(2):126-134. doi: 10.1177/2380084418818482. Epub 2019 Feb 15.
citation: Chu CH, Gao SS, Li SK, Wong MC, Lo EC. The effectiveness of the biannual application of silver nitrate solution followed by sodium fluoride varnish in arresting early childhood caries in preschool children: study protocol for a randomised controlled trial. Trials. 2015 Sep 25;16:426. doi: 10.1186/s13063-015-0960-2.