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

Toulouse University Hospital

Status: Unknown

Conditions: Molar Incisor Hypomineralization

Treatments: Procedure: Direct restoration; Procedure: Indirect ceramic restoration

Study type: Interventional

Funder types: Other

Identifiers

NCT04922177

RC31/19/0053

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

• Non-inclusion criteria:

  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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

68 participants in 2 patient groups

CAD/CAM Group

Experimental group

Description:

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

Treatment:

Procedure: Indirect ceramic restoration

Direct method Group

Active Comparator group

Description:

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

Treatment:

Procedure: Direct restoration