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

June 4, 2021 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Toulouse, France, 31062
        • University Hospital of Toulouse
        • Contact:
        • Principal Investigator:
          • Mathieu Marty
        • Sub-Investigator:
          • Karim Nasr
        • Sub-Investigator:
          • Sabine Joniot
        • Sub-Investigator:
          • Emmanuelle Noirrit
        • Sub-Investigator:
          • Alice Broutin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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)

      -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CAD/CAM Group
For the CAD/CAM group, an indirect ceramic restoration will be made using an optical impression.
Procedure: Indirect ceramic restoration
Indirect ceramic restoration using an optical impression.
ACTIVE_COMPARATOR: Direct method Group
For the direct method group, a restoration using a Glass Ionomer Cement will be performed.
Procedure: Direct restoration
Restoration using a Glass Ionomer Cement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment effect
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure
Time Frame: 3 months
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
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Mathieu MARTY, University Hospital of Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2021

Primary Completion (ANTICIPATED)

June 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

June 4, 2021

First Submitted That Met QC Criteria

June 4, 2021

First Posted (ACTUAL)

June 10, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 4, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/19/0053

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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