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NCT04922177
Computer-aided Design/Computer-aided Manufacturing for Mild to Moderate Molar Incisor Hypomineralization Treatment
Conditions: Molar Incisor Hypomineralization
Sex: All
Ages: 7 Years – 12 Years
Healthy volunteers: No
Phase: NA
Enrollment: 68
Sponsor: University Hospital, Toulouse
Location: University hospital of Toulouse Toulouse
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.
Eligibility 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)
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Source: ClinicalTrials.gov (NCT04922177). StuddyBuddy aggregates publicly available trial information.