Restoration of Permanent Molars Affected With (MIH) Using Composite Restorations or Preformed Metal Crowns

Study Overview
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Brief Summary
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The aim of this study is to compare clinical outcome of using direct esthetic composite restorations in managing MIH cases and the use of preformed metal crowns.

Detailed Description
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Molar incisor hypomineralization can represent a serious and challenging clinical management problem. Children with MIH require higher levels of treatment needs and demonstrate considerable management problems. For most severely affected MIH molars, direct esthetic restorative materials or preformed metal crowns will be the treatments to choose between. A number of aspects which could support decision-making, however, are not clearly demarcated. First and foremost, it is not clear if both treatments are similarly acceptable for patients and providers.

Official Title
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Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns : Two-arm Randomized Controlled Trial (Part III)

Conditions
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Molar Incisor Hypomineralization

Intervention / Treatment
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* Procedure: Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with MIH 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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No

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 restoration<br>Bulk-fill composite (Filtek bulk flow, 3M Espe ) will be used and covered using a nanohybrid copmosite (filtek XT, 3M Espe ) | Procedure: Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe)<br>* Covering the affected molar with preformed metal crown cemented by glass ionomer lutting cement<br>|
| Active Comparator: Preformed metal crowns<br>Preformed stainless-steal crowns cemented by glass ionomer lutting cement (ketac cem. 3M Espe ) | Procedure: Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe)<br>* Covering the affected molar with preformed metal crown cemented by glass ionomer lutting cement<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 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of the treatment Binary (yes or no ) | Questionnaire | 12 month | 
| Restoration quality score index | (FDI criteria: criterion marginal adaptation | 12 month | 
| Health-related quality of life changes by the therapies | Measured as difference in child perceptions Questionnaire CPQ 8-10/11-14) | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MIH