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

NCT04922177 | Unknown

• 1 other identifier: RC31/19/0053
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Molar Incisor Hypomineralization

Keywords

Molar Incisor Hypomineralization; Direct restauration; Computer-aided design (CAD); Computer-aided manufacturing (CAM)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Failure

  3 months

• Failure

  12 months

Study Arms (2)

CAD/CAM Group

EXPERIMENTAL

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

Procedure: Indirect ceramic restoration

Direct method Group

ACTIVE COMPARATOR

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

Procedure: Direct restoration

Interventions

Indirect ceramic restoration PROCEDURE

Indirect ceramic restoration using an optical impression.

CAD/CAM Group

Direct restoration PROCEDURE

Restoration using a Glass Ionomer Cement

Direct method Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Oral consent of the child.
• 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)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University hospital of Toulouse

Toulouse, 31062, France

Location

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mathieu MARTY

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathieu MARTY

CONTACT

06.79.97.47.11; marty.mat@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 10, 2021

Record last verified: 2021-06

Locations

FR (1)