Bone Anchored Carriere Motion Appliance

M

Mansoura University

Status

Enrolling

Conditions

Malocclusion, Angle Class II

Treatments

Device: Carriere motion appliance

Study type

Interventional

Funder types

Other

Identifiers

NCT05499221
A01040122

Details and patient eligibility

About

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).

Full description

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.

Enrollment

32 estimated patients

Sex

All

Ages

11 to 16 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

32 participants in 2 patient groups

Conventional anchorage
Active Comparator group
Description:
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.
Treatment:
Device: Carriere motion appliance
Skeletal anchorage
Experimental group
Description:
Closing coil springs will be attached from the maxillary canine to the infrazygomatic miniscrews bilaterally
Treatment:
Device: Carriere motion appliance

Trial contacts and locations

0

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Central trial contact

Ahmed A. El-Bialy, PhD; Eglal A. Ghozy, BDS, MDs

Data sourced from clinicaltrials.gov

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