Arrest of caries using different silver fluoride solutions in the Healthy Kids Cambodia project

Not Applicable

Completed

• Conditions: Oral Health; Dental caries

• Registration Number: ISRCTN87596444
• Lead Sponsor: SDI Limited

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32715116/ results (added 19/08/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33370847/ (added 27/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-07
• Study Completion: 2020-03-31
• Last Update Posted: 10 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 421

Inclusion Criteria

1. Children with one or more active carious lesions in primary tooth not involving the pulp
2. Participants who will begin the Healthy Kids Cambodia project in Takeo and Kampot provinces during the 2018-2019 academic year
3. Children in Grade 5 or below (age range 6-to 11 years of age)

Exclusion Criteria

1. Children who are unable to provide adequate contact details/alternative contacts for reliable follow-up
2. Grade 6 and above children
3. Children belonging to families who have a plan to shift out of the region in the 12 months following recruitment
4. Children for whom their parents refuse consent at any stage during the study
5. Children who refuse assent at any stage during the study
6. Children with no teeth that are eligible to be included in the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stability of carious lesions defined based on (a) lesion progression (b) lesion colour and (c) lesion texture at 6 months and 12 months. Method for measurement of outcomes will be through clinical observation of the size of the carious lesion using the International Caries Detection and Assessment System version II (ICDAS-II) as well as observation of the color of the carious lesion and the hardness of the carious lesion.

Secondary Outcome Measures

Name	Time	Method
The presence or absence of oral symptoms as defined by the presence or absence of an ‘impact’ on oral symptoms using the oral symptoms domain of the previously validated Child Perceptions Questionnaire at 6 months and 12 months