Restoration Quality in Molars Affected by Molar Incisor Hypo Mineralization

Study Overview
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Brief Summary
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Restoration quality of molars affected by MIH using two different types of restorations direct composite and preformed crowns

Detailed Description
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MIH or molar incisor hypomineralization is one of the difficult clinical situations to be managed by dentists the aim of this study is to specify which is the better treatment among composite restorations and preformed crowns in terms of gingival health patient satisfaction pain hypersensetivity acceptability by the patienat hypersensetivity and the need for future retreatment

Official Title
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Restoration Quality in Molars Affected by Molar-incisor-hypomineralization Using Composite Restorations or Preformed Metal Crowns: Two-arm Randomized Controlled Trial.

Conditions
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Molar Incisor Hypomineralization

Intervention / Treatment
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* Procedure: preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: .Children with molar incisor hypo mineralization in one fully erupted molar or more. Age ranging from 7-12 years. Cooperative children Good general health Exclusion Criteria: Patients participating in other experiments .Patients with parents planning to move away within the following year. Patients with only mildly affected MIH molars that do not require extensive restorative treatment. MIH-affected molars that have a very poor prognosis and require extraction. First permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Direct composite restorations<br>bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used and covered using a nanohybrid composite, (Filtek XT, 3M Espe) | Procedure: preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)<br>* covering the affected molar with preformed metal crown cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)<br>|
| Active Comparator: preformed metal crowns<br>preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe) | Procedure: preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)<br>* covering the affected molar with preformed metal crown cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain after the restoration .Binary (yes or No) | questionnaire | 12 MONTHS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of the treatment Binary (yes or No) | questionnaire | 12 months | 
| restoration quality Score index | (FDI criteria; criterion marginal adaptation) | 12 months | 
| health-related quality of life changes by the therapies | measured as difference in Child Perceptions Questionnaire CPQ 8-10/11-14) | 12 months |