Bone Anchored Carriere Motion Appliance

NCT05499221 | Completed FDA Device

• 1 other identifier: A01040122
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Malocclusion, Angle Class II

Keywords

Carriere motion appliance; Distalization; Skeletal anchorage; Infrazygomatic miniscrews

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

Conventional anchorage

ACTIVE COMPARATOR

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

Skeletal anchorage

EXPERIMENTAL

Closing coil springs will be attached from the maxillary canine to the infrazygomatic miniscrews bilaterally

Device: Carriere motion appliance

Interventions

Carriere motion appliance DEVICE

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.

Conventional anchorage; Skeletal anchorage

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Systemic conditions that may interfere with the treatment.
• Bad habits that might jeopardize the appliance.
• Transverse discrepancy.
• Previous orthodontic treatment.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

MansouraU, faculty of dentistry, orthodontics department

Al Mansurah, Egypt

Location

Related Publications (1)

• Ghozy EA, Albelasy NF, Shamaa MS, El-Bialy AA. Cephalometric and digital model analysis of dentoskeletal effects of infrazygomatic miniscrew vs. Essix- anchored Carriere Motion appliance for distalization of maxillary buccal segment: a randomized clinical trial. BMC Oral Health. 2024 Jan 31;24(1):152. doi: 10.1186/s12903-024-03925-3.

  PMID: 38297285 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Eglal A. Ghozy, BDS, MDS

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Ahmed A. El-bialy, PhD

  Mansoura University

  STUDY CHAIR

• Marwa S. Shamaa, PhD

  Mansoura University

  STUDY DIRECTOR

• Nehal F. Albelasy, PhD

  Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: data will be sent blinded for statistical analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Subjects will be randomly allocated into two groups: 1. Conventional anchorage CMA group (CAG): conventional mandibular anchorage using Essix retainer. 2. 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.

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 12, 2022
• Study Start: January 26, 2022
• Primary Completion: June 26, 2023
• Study Completion: August 26, 2023
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)