Clinical trial NCT04922177: Computer-aided Design/Computer-aided Manufacturing for Mild to Moderate Molar Incisor Hypomineralization Treatment
Official title: Computer-aided Design/Computer-aided Manufacturing for Mild to Moderate Molar Incisor Hypomineralization Treatment : a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Molar Incisor Hypomineralization
Keywords: Molar Incisor Hypomineralization
Direct restauration
Computer-aided design (CAD)
Computer-aided manufacturing (CAM)
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 68
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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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Primary outcomes:
measure: Treatment effect
timeFrame: 6 months
Secondary outcomes:
measure: Failure
timeFrame: 3 months
measure: Failure
timeFrame: 12 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University hospital of Toulouse
Study officials:
affiliation: University Hospital of Toulouse
name: Mathieu MARTY
role: PRINCIPAL_INVESTIGATOR
References: