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Clinical Trials/NCT05499221
NCT05499221CompletedNot Applicable

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

Mansoura University1 site in 1 country32 target enrollmentStarted: January 26, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
32
Locations
1
Primary Endpoint
Skeletal changes

Study Overview

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).

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

data will be sent blinded for statistical analysis

Eligibility Criteria

Ages
11 Years to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

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.

Intervention: Carriere motion appliance (Device)

Skeletal anchorage

Experimental

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

Intervention: Carriere motion appliance (Device)

Outcomes

Primary Outcomes

Skeletal changes

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

degrees

Treatment duration

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

months

Dental changes

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

degrees

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eglal Ahmed

Dr.

Mansoura University

Study Sites (1)

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