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

Primary Purpose

Molar Incisor Hypomineralization

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Indirect ceramic restoration
Direct restoration
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Molar Incisor Hypomineralization focused on measuring Molar Incisor Hypomineralization, Direct restauration, Computer-aided design (CAD), Computer-aided manufacturing (CAM)

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

  • 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)

      -

Sites / Locations

  • University hospital of Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CAD/CAM Group

Direct method Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Failure
Failure diagnosed according to the degree of demineralisation measured, every 3 months following the restoration, by laser fluorescence at the peripheral tooth/restoration joint.
Failure
Failure diagnosed according to the degree of demineralisation measured, every 12 months following the restoration, by laser fluorescence at the peripheral tooth/restoration joint.

Full Information

First Posted
June 4, 2021
Last Updated
June 4, 2021
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT04922177
Brief Title
Computer-aided Design/Computer-aided Manufacturing for Mild to Moderate Molar Incisor Hypomineralization Treatment
Acronym
MIhCFAO
Official Title
Computer-aided Design/Computer-aided Manufacturing for Mild to Moderate Molar Incisor Hypomineralization Treatment : a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molar Incisor Hypomineralization
Keywords
Molar Incisor Hypomineralization, Direct restauration, Computer-aided design (CAD), Computer-aided manufacturing (CAM)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAD/CAM Group
Arm Type
Experimental
Arm Description
For the CAD/CAM group, an indirect ceramic restoration will be made using an optical impression.
Arm Title
Direct method Group
Arm Type
Active Comparator
Arm Description
For the direct method group, a restoration using a Glass Ionomer Cement will be performed.
Intervention Type
Procedure
Intervention Name(s)
Indirect ceramic restoration
Intervention Description
Indirect ceramic restoration using an optical impression.
Intervention Type
Procedure
Intervention Name(s)
Direct restoration
Intervention Description
Restoration using a Glass Ionomer Cement
Primary Outcome Measure Information:
Title
Treatment effect
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Failure
Description
Failure diagnosed according to the degree of demineralisation measured, every 3 months following the restoration, by laser fluorescence at the peripheral tooth/restoration joint.
Time Frame
3 months
Title
Failure
Description
Failure diagnosed according to the degree of demineralisation measured, every 12 months following the restoration, by laser fluorescence at the peripheral tooth/restoration joint.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
inclusion criteria: 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. 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). Oral consent of the child. Non-inclusion criteria: 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) -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu MARTY
Phone
06.79.97.47.11
Email
marty.mat@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu MARTY
Organizational Affiliation
University Hospital of Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital of Toulouse
City
Toulouse
ZIP/Postal Code
31062
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu Marty
Email
marty.mat@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Mathieu Marty
First Name & Middle Initial & Last Name & Degree
Karim Nasr
First Name & Middle Initial & Last Name & Degree
Sabine Joniot
First Name & Middle Initial & Last Name & Degree
Emmanuelle Noirrit
First Name & Middle Initial & Last Name & Degree
Alice Broutin

12. IPD Sharing Statement

Learn more about this trial

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

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