Bone Anchored Carriere Motion Appliance

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

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).

Study Overview

• Status: Recruiting
• Conditions: Malocclusion, Angle Class II
• Intervention / Treatment: Device: Carriere motion appliance

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.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eglal A. Ghozy, BDS, MDs; Phone Number: 00201121441414; Email: eglalahmed@mans.edu.eg
• Study Contact Backup: Name: Ahmed A. El-Bialy, PhD; Phone Number: 00201002200017; Email: bialy@doctor.com

Study Locations

• Egypt
  • Mansoura, Egypt
    • Recruiting
    • MansouraU, faculty of dentistry, orthodontics department
    • Principal Investigator: Eglal A. Ghozy, BDS, MDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 16 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Conventional anchorage; 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; 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.
EXPERIMENTAL: Skeletal anchorage; Closing coil springs will be attached from the maxillary canine to the infrazygomatic miniscrews bilaterally	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.

What is the study measuring?

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)
Dental changes	degrees	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)

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Eglal A. Ghozy, BDS, MDS, Mansoura University; Study Chair: Ahmed A. El-bialy, PhD, Mansoura University; Study Director: Marwa S. Shamaa, PhD, Mansoura University; Study Director: Nehal F. Albelasy, PhD, Mansoura University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 26, 2022
• Primary Completion (ANTICIPATED): June 26, 2023
• Study Completion (ANTICIPATED): October 26, 2023

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (ACTUAL): August 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Distalization; Carriere motion appliance; Skeletal anchorage; Infrazygomatic miniscrews
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite
• Other Study ID Numbers: A01040122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes