Status:
COMPLETED
Silver Diamine Fluoride and Papain-Based Gel for Management of MIH-affected Molar in Paediatric Patients
Lead Sponsor:
University of Malaya
Conditions:
Molar Incisor Hypomineralization
Dental Caries
Eligibility:
All Genders
5-15 years
Phase:
NA
Brief Summary
Molar incisor hypomineralization (MIH) is a developmental defect of enamel affecting the first permanent molar and frequently the incisors with a prevalence of 16-16.9% in Malaysia. They presented wit...
Detailed Description
This is a three-arm parallel randomized controlled trial and will be performed in participants between the age of 5 to 15 years presented with hypomineralised molar of MIH in origin. Clinical assessm...
Eligibility Criteria
Inclusion
- Healthy with ability to comprehend instruction and perform oral hygiene care independently
- Hypomineralised First Permanent Molar with:
- 1 Post Eruptive Breakdown (Code 3)
- 2 Atypical restoration (Code 4) which is unsatisfactory or with secondary caries that require replacement
- 3 Atypical caries (Code 5) with enamel breakdown
Exclusion
- Patient with silver allergy
- First Permanent Molar with:
- 1 Non-MIH defect
- 2 White, creamy demarcated yellow or brown opacities (Code 2)
- 3 Good satisfactory atypical restoration (Code 4)
- 4 Atypical caries (Code 5) with pulpal involvement -Irreversible pulpitis and pulpal necrosis
- 5 Extensive coronal breakdown (Code 7)
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04710927
Start Date
December 1 2019
End Date
November 30 2021
Last Update
July 20 2023
Active Locations (1)
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1
Faculty of Dentistry, University of Malaya
Kuala Lumpur, Kuala Lumpur, Malaysia, 50603