Clinical trial NCT05631353: TADs Anchored vs Conventional Anchored Carriere Motion Appliance
Official title: Carriere Motion Appliance in The Treatment of Class II Malocclusion Using Different Methods of Anchorage Control (Cone Beam Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class II Malocclusion
Keywords: Carriere Motion Appliance
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 20
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

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: Assiut
country: Egypt
facility: Alazhar university
Study officials:
affiliation: saleh.anwar@azhar.edu.eg
name: Saleh Anwar El-sayed, professor
role: STUDY_CHAIR
References:
citation: Carriere L. A new Class II distalizer. J Clin Orthod. 2004 Apr;38(4):224-31. No abstract available.
citation: Rodriguez HL. Unilateral application of the Carriere Distalizer. J Clin Orthod. 2011 Mar;45(3):177-80. No abstract available.
citation: Wilson B, Konstantoni N, Kim KB, Foley P, Ueno H. Three-dimensional cone-beam computed tomography comparison of shorty and standard Class II Carriere Motion appliance. Angle Orthod. 2021 Jul 1;91(4):423-432. doi: 10.2319/041320-295.1.