Management of Molar Incisor Hypomineralization With Silver Diamine Fluoride

Study Overview
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Brief Summary
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The purpose of this study is to evaluate and compare the clinical performance of Silver diamine Fluoride (SDF) and Silver diamine fluoride + Atraumatic resin restoration (SDF+ARR) on molars with MIH

Detailed Description
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SDF and SDF+ARR will be placed on two permanent molar teeth with MIH, in a split mouth design. 100 patients will be included in the study. The teeth will be randomized into two groups according to the dental restorative material. Group 1: SDF only ((Riva Star) 2: SDF (Riva Star) +ARR (Equia Forte). The US Public Health Service criteria (secondary caries, anatomical form, surface roughness, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of atraumatic resin restorations. The restorations will be evaluated at baseline and 1., 6., 12., 18., 24. months. Intra-oral photos will be taken directly after treatment and at control appointments to evaluate discoloration and seconder caries under magnification. The data will be analysed statistically using Fisher's Exact Test; and the Kaplan-Meier and Wilcoxon method will be used to estimate survival percentages.

Official Title
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Clinical Evaluation of Permanent Molars With Molar Incisor Hypomineralization Treated With Silver Diamine Fluoride or Silver Diamine Fluoride+Atraumatic Restorative Technique

Conditions
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Dental Caries, Molar Incisor Hypomineralization

Intervention / Treatment
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* Device: SDF only
* Device: SDF+ARR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients and parents of the patients who accept to participate and sign the informed consent Patients whose molar teeth are diagnosed as molar incisor hypomineralization by EAPD Teeth that are fully erupted Patients who have at least two permanent first molars that need fissure sealant Teeth that have white-yellow-brown discoloration that indicate high-caries risk Exclusion Criteria: Teeth that are previously restored or have caries Patients who have orthodontic treatment Patients who are not cooperative for the dental procedure Teeth that have dental fluorosis or enamel malformation according to the specific syndromes

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SDF only<br>SDF will be applied on molars with MIH | Device: SDF only<br>* Molar with MIH will be treated with SDF<br>|
| Active Comparator: SDF+ARR<br>SDF+ARR will be applied on molars with MIH | Device: SDF+ARR<br>* Molar with MIH will be treated with SDF+ARR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance of SDF and SDF+ARR on molars with MIH | The US Public Health Service criteria (secondary caries, anatomical form, surface roughness, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of atraumatic resin restorations. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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molar incisor hypomineralization, silver diamine fluoride