Assessing Benefits Of Treatment Of Dental Caries Using 38% Silver Diamine Fluoride And Placebo Among Primary School Children In Hyderabad City: A Randomized Controlled Trial.
- Conditions
- DENTAL CARIESDental caries on smooth surface,
- Registration Number
- CTRI/2020/11/029210
- Lead Sponsor
- H Sai Sandeep
- Brief Summary
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|Untreated dental caries is a global pandemic. Due to limited financial resources, poor access to basic oral care, and the high cost of restorative treatment, children of low-income nations have their general health, social well-being, and education opportunities affected by untreated dental caries .
- In this context, there is interest in simple treatments to halt progress of cavities (caries lesions) after tooth decay onset .
Arresting Caries Treatment (ACT) has been proposed to manage untreated dental caries in children of disadvantaged communities.
- Topical silver diamine fluoride is a clear liquid that is painted on the active lesion surface in milligram amounts and arrests the lesion.
- Cleared by the Food and Drug Administration in 2014 as a treatment for sensitive teeth and used off-label for the treatment of cavities in the United States since 2015,12 clinical trials outside the United States have documented caries arrest.
- Silver diamine fluoride (SDF) treatment has been identiï¬ed as a potential solution to address the dental public health issues of untreated dental caries and insufï¬cient access to care especially among disadvantaged children.
- The current study will assess the short term effectiveness of 38 percent SDF in arresting active caries lesions in children.
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|· The Aim of this randomized controlled trial was to investigate and compare the short term effectiveness of topically applied 38% silver diamine fluoride with a placebo in arresting caries lesions in primary school children in Hyderabad city.
Arandomized controlled trial will be carried out among 61 Primary school children inHyderabad city. The caries status of the children will be assessed using Nyvadcriteria (1999), wherein children with score 3 of Nvyad criteria will be included in the study. Thechildren will be randomly assigned to Active Group (n=31) and Control Group (n=30).The Active group will receive topicalapplication of 38% SDF and the control group receives topical application ofsterile water as ( placebo). Examination of caries lesions will be assessed at Baselineand after 21st day. On 21st day the number of lesions that are arrested will be evaluated based on the score 6 of Nyvad criteria.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
Children having at least one untreated cavitated active caries lesion based on Nyvad criteria.[code :3 Enamel/dentin cavity easily visible with the naked eye; surface of cavity feels soft or leathery on gentle probing ] ï‚¢ Parents who gave written informed consent .
Children not willing to participate in the study ï‚¢ Presence of any gingival or perioral ulceration or stomatitis or presence of a tooth abscess.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Caries arrest 30 days
- Secondary Outcome Measures
Name Time Method Inhibits caries progression 30 Days
Trial Locations
- Locations (1)
zilla Primary Parishad School
🇮🇳Hyderabad, TELANGANA, India
zilla Primary Parishad School🇮🇳Hyderabad, TELANGANA, IndiaD ShravyaPrincipal investigator9052804847shravyadeverashetty@gmail.com