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

NCT ID: NCT04922177

Last Updated: 2021-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2023-12-31

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.

Conditions

Molar Incisor Hypomineralization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CAD/CAM Group

For the CAD/CAM group, an indirect ceramic restoration will be made using an optical impression.

Group Type: EXPERIMENTAL

Indirect ceramic restoration

Intervention Type: PROCEDURE

Indirect ceramic restoration using an optical impression.

Direct method Group

For the direct method group, a restoration using a Glass Ionomer Cement will be performed.

Group Type: ACTIVE_COMPARATOR

Direct restoration

Intervention Type: PROCEDURE

Restoration using a Glass Ionomer Cement

Interventions

Indirect ceramic restoration

Indirect ceramic restoration using an optical impression.

Intervention Type: PROCEDURE

Direct restoration

Restoration using a Glass Ionomer Cement

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Child from 7 to 12 years old presenting a mild to moderate HIN on at least one permanent first molar requiring reconstitution.

2. Child presenting a state of anxiety compatible with the provision of oral care (score on the Venham scale modified by Veerkamp below 2).

3. Child affiliated to or benefiting from a social security scheme.

4. 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).

5. Oral consent of the child.

1. Child presenting an allergy or a history of allergy to one of the constituents of biomaterials

2. Child with fluorosis

3. Child with amelogenesis imperfecta

4. Child with pacemaker (contraindication to CAD/CAM)

-

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mathieu MARTY

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Toulouse

Locations

University hospital of Toulouse

Toulouse, , France

Countries

France

Central Contacts

Mathieu MARTY

Role: CONTACT

marty.mat@chu-toulouse.fr

06.79.97.47.11

Facility Contacts

Mathieu Marty

Role: primary

marty.mat@chu-toulouse.fr

Other Identifiers

RC31/19/0053

Identifier Type: -

Identifier Source: org_study_id