Bone Anchored Carriere Motion Appliance

Malocclusion, Angle Class II Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05499221
• Other study ID #: A01040122
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2022
• Est. completion date: October 26, 2023

Study information

• Verified date: August 2022
• Source: Mansoura University
• Contact: Eglal A. Ghozy, BDS, MDs
• Phone: 00201121441414
• Email: eglalahmed[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: October 26, 2023
• Est. primary completion date: June 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 16 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle Class II

Intervention

Device:
• Carriere motion appliance
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.

Locations

Country	Name	City	State
Egypt	MansouraU, faculty of dentistry, orthodontics department	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment duration	months	from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)
Primary	Skeletal changes	degrees	from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)
Primary	Dental changes	degrees	from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)