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

Molar Incisor Hypomineralization Clinical Trial

— MIhCFAO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04922177
• Other study ID #: RC31/19/0053
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2021
• Est. completion date: December 2023

Study information

• Verified date: June 2021
• Source: University Hospital, Toulouse
• Contact: Mathieu MARTY
• Phone: 06.79.97.47.11
• Email: marty.mat[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

• 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)

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Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralization

Intervention

Procedure:
• Indirect ceramic restoration
Indirect ceramic restoration using an optical impression.
• Direct restoration
Restoration using a Glass Ionomer Cement

Locations

Country	Name	City	State
France	University hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	3 months
Secondary	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.	12 months