Computer-aided Design/Computer-aided Manufacturing for Mild to Moderate Molar Incisor Hypomineralization Treatment

Study Overview
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Brief Summary
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Molar Incisor Hypomineralization (MIH) is a disease causing a structural defect in the enamel of permanent teeth. The treatment of these teeth consists of the removal of the affected part of the tooth and its reconstitution. Classically, the restoration is done with a resin in direct method. With the development of Computer-aided design (CAD) and Computer-aided manufacturing (CAM), it is possible to make a custom-made part to replace the affected part of the tooth. The main objective is to describe the effect of the 6-month management of CAD/CAM type restorations compared to direct restorations, performed in children aged 7 to 12 years with mild to moderate MIH on permanent molar teeth.

Detailed Description
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Molar Incisor Hypomineralization (MIH) is a structural defect of the enamel affecting at least one of the first four permanent molars. The prevalence is high, ranging from 20% to 40% of children. The consequences of MIH are multiple, including pain during food intake or an increased risk for the development of carious disease. The current standard protocol for mild to moderate MIH is the use of direct restorations (Glass Cement Ionomer type). However, this therapy is not suitable due to frequent failures. In terms of longevity, indirect restorations are superior to direct restorations. CAD/CAM in dentistry offers the possibility of making these inlay/onlay type perennial coronary restorations. It is faster to implement and does not require a conventional impression.

Official Title
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Computer-aided Design/Computer-aided Manufacturing for Mild to Moderate Molar Incisor Hypomineralization Treatment : a Pilot Study

Conditions
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Molar Incisor Hypomineralization

Intervention / Treatment
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* Procedure: Indirect ceramic restoration
* Procedure: Direct restoration


Participation Criteria
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Eligibility Criteria
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inclusion criteria: Child from 7 to 12 years old presenting a mild to moderate HIN on at least one permanent first molar requiring reconstitution. Child presenting a state of anxiety compatible with the provision of oral care (score on the Venham scale modified by Veerkamp below 2). Child affiliated to or benefiting from a social security scheme. Free, informed and signed consent by the parent(s)/holder(s) of parental authority and the investigator (at the latest on the day of inclusion and before any examination required by the research). Oral consent of the child. Non-inclusion criteria: Child presenting an allergy or a history of allergy to one of the constituents of biomaterials Child with fluorosis Child with amelogenesis imperfecta Child with pacemaker (contraindication to CAD/CAM) -

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAD/CAM Group<br>For the CAD/CAM group, an indirect ceramic restoration will be made using an optical impression. | Procedure: Indirect ceramic restoration<br>* Indirect ceramic restoration using an optical impression.<br>|
| Active Comparator: Direct method Group<br>For the direct method group, a restoration using a Glass Ionomer Cement will be performed. | Procedure: Direct restoration<br>* Restoration using a Glass Ionomer Cement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment effect | The effect of the management of the MIH will be assessed by the occurrence of failure. Failure will be diagnosed from the degree of demineralisation measured, by laser fluorescence at the peripheral tooth/restoration joint. The values collected range from 0 to 99 and are categorised into 3 situations : From 0 to 12: situation without demineralization, tight seal. From 13 to 24: start of demineralization ≥ 25: therapeutic failure, non-watertight seal, restoration to be redone without delay. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure | Failure diagnosed according to the degree of demineralisation measured, every 3 months following the restoration, by laser fluorescence at the peripheral tooth/restoration joint. | 3 months | 
| Failure | Failure diagnosed according to the degree of demineralisation measured, every 12 months following the restoration, by laser fluorescence at the peripheral tooth/restoration joint. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Molar Incisor Hypomineralization, Direct restauration, Computer-aided design (CAD), Computer-aided manufacturing (CAM)