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Clinical Trials/NCT05631353
NCT05631353CompletedNot Applicable

Carriere Motion Appliance in The Treatment of Class II Malocclusion Using Different Methods of Anchorage Control (Cone Beam Study)

Al-Azhar University1 site in 1 country20 target enrollmentStarted: January 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Treatment duration

Study Overview

Brief Summary

Carriere Motion appliance (CMA) was designed to correct 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 revoke the adverse effects of CMA with class II elastics, we can use the CMA to distalize the maxillary posterior segment with TADs anchorage using miniscrews. The aim of this study is to evaluate TADs anchored CMA vs. conventionally anchored CMA for distalization of the maxillary buccal segment.

Detailed Description

Twenty class II malocclusion patients with age (11-16) years will be randomly allocated in the two groups:

Group I: Patients will be treated by Carriere Motion Appliance using passive lingual arch.

Group II: Patients will be treated by Carriere Motion Appliance using direct mini-screw.

For each patient, two CBCT will be obtained: one preoperatively and another after completion of distalization.

Comparing skeletal and dental measurements obtained from CBCT radiographs obtained prior to treatment (T0) and immediately after correction of class II and remval of the appliance (T1).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, 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

  • •Adolescent patients aged 11-17 years.
  • •Unilateral or bilateral Class II molar relationship.
  • •Bilateral Class II canine relationship.
  • •No history of previous orthodontic treatment.
  • •No malformed teeth, impacted teeth and unerupted teeth.
  • •No systemic disease.
  • •Good oral hygiene.
  • •No abnormal pressure habit.
  • •No periodontal diseases.
  • •No missing teeth in maxillary arch.

Exclusion Criteria

  • •The need for extraction in the lower arch.
  • •Posterior crossbite.
  • •Presence of any craniofacial anomalies.
  • •Patients with syndromes.

Arms & Interventions

Group I: Patients will be treated by Carriere Motion Appliance using passive lingual arch .

Active Comparator

Conventional mandibular anchorage 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)

Group II: Patients will be treated by Carriere Motion Appliance using direct mini-screw.

Active Comparator

TADs mandibular anchorage. 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)

Outcomes

Primary Outcomes

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

Skeletal 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

Abdelshafy Ali

Assistant lecturer

Al-Azhar University

Study Sites (1)

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