Efficacy of Skeletal Anchorage (MINISCREW)

Study Overview
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Brief Summary
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The main objective of the investigators' study is to assess the efficacy of a course of treatment using skeletal anchorage (MINISCREW) as compared with treatment involving dental anchorage (reference) during dentofacial orthopedic treatment.

Detailed Description
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Multicenter prospective study on patients aged between 12 and 50 years, requiring orthodontic treatment with premolar extractions and closure of the extraction spaces by distalization of the 6 anterior teeth. In the experimental group (50 patients) distalization will be performed using skeletal anchorage (MINISCREW). In the control group (50 patients), distalization will be by dental anchorage. The main evaluation criterion will be extraction space closure after 8 months of treatment. Angle class I cuspid and the parallelism of the dental axes will also be taken into account. Evaluations will be made by very precise radiological analysis using 3D CT-scan. Examinations will be done before and after closure of the extraction sites and will assess treatment efficacy using skeletal anchorage versus dental anchorage. Patients will also be requested to complete a satisfaction questionnaire. The study will comprise an inclusion appointment during which patient consent will be obtained and a regular monthly appointment during the 8 months of active treatment and space closure.

Official Title
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Study of the Efficacy of Skeletal Anchorage (MINISCREW) Compared to Dental Anchorage During Orthodontic Treatment

Conditions
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Tooth Extraction Status Nos

Intervention / Treatment
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* Device: Skeletal anchorage (MINISCREW)
* Device: dental anchorage


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Aged from 12 to 50 years old Patient need orthodontic treatment with extraction of 2 maxillary bicuspid Patient has signed informed consent Exclusion criteria: Patient younger than 12 and older than 50 years old Patient without social security affiliation Patient with a medical condition that indicates against orthodontic treatment

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MINISCREW<br>device | Device: Skeletal anchorage (MINISCREW)<br>* Skeletal anchorage<br>* Other names: Skeletal anchorage;|
| Active Comparator: Reference<br>dental anchorage | Device: dental anchorage<br>* dental anchorage (reference)<br>* Other names: dental anchorage (reference);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We measure space extraction close after 8 months treatment. Angle class I cuspid and the parallelism of the dental axes will also be taken into account. |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MINISCREW stability |  | 8 months | 
| Anchorage teeth stability |  | 8 months | 
| Success and Failure implantation percentage |  | 8 months | 
| MINISCREW surgery difficulty |  | during the surgery act | 
| Patient satisfaction |  | at 1 month and at 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MINISCREW, space extraction closure, anchorage, Orthodontic Treatment, Extraction of 2 Maxillary Premolar, closing of extraction space, patient aged from 12 to 50 years old