Bone Anchored Carriere Motion Appliance

Study Overview
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Brief Summary
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Carriere Motion appliance (CMA) was designed to change a Class II molar relationship into a Class I relationship by distalizing the whole posterior maxillary segment by means of class II elastics and mandibular anchorage. To eliminate the adverse effects of CMA with class II elastics, we can use the CMA to distalize the maxillary posterior segment with intra-arch anchorage using infrazygomatic miniscrews. The aim of this study is to evaluate skeletaly anchored CMA for distalization of the maxillary buccal segment vs. conventionally anchored CMA by comparing skeletal and dental measurements obtained from lateral cephalometric radiographs obtained prior to treatment (T0) and immediately after correction of class II and remval of the appliance (T1).

Detailed Description
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Thirty-two class II malocclusion patients with age (11-16) years will be randomly allocated in the two groups: Conventional anchorage CMA group (CAG): conventional mandibular anchorage using Essix retainer. Skeletal anchorage CMA group (SAG): anchorage by infra-zygomatic miniscrews. In the CAG, Class II elastics will be attached from the maxillary canine to the mandibular first molar bilaterally with Essix retainer in the lower arch as anchorage means. In the SAG, closing coil spring will be attached from the maxillary canine to the infrazygomatic miniscrews bilaterally. For each patient, two lateral cephalograms will be obtained: one preoperatively and another after completion of distalization. Model measurements will be made using the attached 3Shape computer software.

Official Title
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Segmental Distalization by Bone Anchored Carriere Motion Appliance vs. Conventional One

Conditions
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Malocclusion, Angle Class II

Intervention / Treatment
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* Device: Carriere motion appliance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age (11-16) years. Full permanent dentition. Class II malocclusion with at least an end-on Class II molar relationship bilaterally. Exclusion Criteria: Systemic conditions that may interfere with the treatment. Bad habits that might jeopardize the appliance. Transverse discrepancy. Previous orthodontic treatment.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Subjects will be randomly allocated into two groups: Conventional anchorage CMA group (CAG): conventional mandibular anchorage using Essix retainer. Skeletal anchorage CMA group (SAG): anchorage by infra-zygomatic mini-screws. In the CAG, Class II elastics will be attached from the maxillary canine to the mandibular first molar bilaterally with Essix retainer in the lower arch as anchorage means. In the SAG, the closing coil spring will be attached from the maxillary canine to the infra zygomatic miniscrews bilaterally. For each patient, two lateral cephalograms will be obtained: one preoperatively and another after completion of distalization. Model measurements will be made using the attached 3Shape computer software.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional anchorage<br>Buccal tubes will be bonded on the lower first molars, an alginate impression will be taken for the lower arch with the buccal tubes in place, and a cast will be poured. A hard vacuum sheet of 1.5- mm thickness will be used to fabricate the Essix appliance. The posterior end of the buccal surface will be trimmed in each lower first molar region, creating a window to allow for attachment of the elastics. Class II elastics will be attached from the maxillary canine to the mandibular first molar bilaterally. During the first month, 1/4-inch heavy elastics will be used. In the following months, 3/16-inch heavy elastics will be used. The patients will be instructed to wear the elastics 24 hours per day, except during mealtimes, and to change them daily. | Device: Carriere motion appliance<br>* The CMA will be bonded on the permanent maxillary canine and first molar, and the correct size is chosen according to the manufacturer's instructions.<br>|
| Experimental: Skeletal anchorage<br>Closing coil springs will be attached from the maxillary canine to the infrazygomatic miniscrews bilaterally | Device: Carriere motion appliance<br>* The CMA will be bonded on the permanent maxillary canine and first molar, and the correct size is chosen according to the manufacturer's instructions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment duration | months | from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months) | 
| Skeletal changes | degrees | from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months) | 
| Dental changes | degrees | from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carriere motion appliance, Distalization, Skeletal anchorage, Infrazygomatic miniscrews