N/A
Completed N=57
Silver Diamine Fluoride and Papain-Based Gel for Management of MIH-affected Molar in Paediatric Patients
Molar Incisor Hypomineralization · Dental Caries · Hypomineralization of Enamel
Source: ClinicalTrials.gov NCT04710927 ↗
Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcomePrimary: Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 6 Months — 17; 18; 17 number of Successful MIH affected molars
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 with many problems such as hypersensitivity, increase susceptibility of caries, need for recurrent complex dental treatment, and difficulty to achieve pain control. Silver Diamine Fluoride is a new form of topical fluoride that has been extensively used and recommended for the management of caries in children and adolescents. The influence of organic material removal from artificial dentine lesions by means of surface pre-treatment with deproteinizing agent show favoring result of its use on subsequent remineralization with and without fluoride. The purpose of this trial is to study the clinical outcome of SDF and papain based gel on hypomineralized teeth restored with HVGIC.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 6 Months |
17; 18; 17 | — |
| PRIMARY Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 12 Months |
14; 13; 15 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Healthy with ability to comprehend instruction and perform oral hygiene care independently
- Hypomineralised First Permanent Molar with:
2.1 Post Eruptive Breakdown (Code 3)
2.2 Atypical restoration (Code 4) which is unsatisfactory or with secondary caries that require replacement
2.3 Atypical caries (Code 5) with enamel breakdown
Exclusion Criteria
- Patient with silver allergy
- First Permanent Molar with:
2.1 Non-MIH defect
2.2 White, creamy demarcated yellow or brown opacities (Code 2)
2.3 Good satisfactory atypical restoration (Code 4)
2.4 Atypical caries (Code 5) with pulpal involvement -Irreversible pulpitis and pulpal necrosis
2.5 Extensive coronal breakdown (Code 7)
Data sourced from ClinicalTrials.gov (NCT04710927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.