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Completed

NCT Number: NCT05499221

Bone Anchored Carriere Motion Appliance

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).

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Key information

Conditions

Malocclusion, Angle Class II Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

11 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MansouraU, faculty of dentistry, orthodontics department

Al Mansurah, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Treatment duration

    Time frame: from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)

    months

  2. Skeletal changes

    Time frame: from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)

    degrees

  3. Dental changes

    Time frame: from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)

    degrees

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2022
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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