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

Not Applicable

• Conditions: Molar Incisor Hypomineralization
• Interventions: Procedure: Indirect ceramic restoration; Procedure: Direct restoration

• Registration Number: NCT04922177
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-06
• Study Start: 2021-06
• Study First Submitted: 2021-06-04
• Study First Submitted QC: 2021-06-04
• Last Update Submitted: 2021-06-04
• Study First Posted: 2021-06-10
• Last Update Posted: 2021-06-10
• Primary Completion: 2023-06
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAD/CAM Group	Indirect ceramic restoration	For the CAD/CAM group, an indirect ceramic restoration will be made using an optical impression.
Direct method Group	Direct restoration	For the direct method group, a restoration using a Glass Ionomer Cement will be performed.

Primary Outcome Measures

Name	Time	Method
Treatment effect	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Failure	12 months	Failure diagnosed according to the degree of demineralisation measured, every 12 months following the restoration, by laser fluorescence at the peripheral tooth/restoration joint.

Trial Locations

Locations (1)

University hospital of Toulouse; 🇫🇷 Toulouse, France