Clinical trial NCT05499221: Bone Anchored Carriere Motion Appliance
Official title: Segmental Distalization by Bone Anchored Carriere Motion Appliance vs. Conventional One
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion, Angle Class II
Keywords: Carriere motion appliance
Distalization
Skeletal anchorage
Infrazygomatic miniscrews
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 32
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Systemic conditions that may interfere with the treatment.
2. Bad habits that might jeopardize the appliance.
3. Transverse discrepancy.
4. Previous orthodontic treatment.

Primary outcomes:
measure: Treatment duration
timeFrame: from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)
measure: Skeletal changes
timeFrame: from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)
measure: Dental changes
timeFrame: from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: MansouraU, faculty of dentistry, orthodontics department
Study officials:
affiliation: Mansoura University
name: Eglal A. Ghozy, BDS, MDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Ahmed A. El-bialy, PhD
role: STUDY_CHAIR
affiliation: Mansoura University
name: Marwa S. Shamaa, PhD
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Nehal F. Albelasy, PhD
role: STUDY_DIRECTOR
References: