Bone Anchored Carriere Motion Appliance

Not Applicable

Completed

• Conditions: Malocclusion, Angle Class II
• Interventions: Device: Carriere motion appliance

• Registration Number: NCT05499221
• Lead Sponsor: Mansoura University

Brief Summary

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

Thirty-two class II malocclusion patients with age (11-16) years will be randomly allocated in the two groups:

1. Conventional anchorage CMA group (CAG): conventional mandibular anchorage using Essix retainer.

2. 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2022-01-26
• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-12
• Primary Completion: 2023-06-26
• Study Completion: 2023-08-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Patients age (11-16) years.
2. Full permanent dentition.
3. Class II malocclusion with at least an end-on Class II molar relationship bilaterally.

Read More

Exclusion Criteria

1. Systemic conditions that may interfere with the treatment.
2. Bad habits that might jeopardize the appliance.
3. Transverse discrepancy.
4. Previous orthodontic treatment.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional anchorage	Carriere motion appliance	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.
Skeletal anchorage	Carriere motion appliance	Closing coil springs will be attached from the maxillary canine to the infrazygomatic miniscrews bilaterally

Primary Outcome Measures

Name	Time	Method
Treatment duration	from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)	months
Dental changes	from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)	degrees
Skeletal changes	from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)	degrees

Trial Locations

Locations (1)

MansouraU, faculty of dentistry, orthodontics department; 🇪🇬 Mansoura, Egypt