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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05631353
Other study ID # Carriere motion appliance
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date August 2024

Study information

Verified date January 2024
Source Al-Azhar University
Contact Abdelshafy Ali Megahed, PHD
Phone 00201099353710
Email abdelshafy.dentist@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date August 2024
Est. primary completion date April 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 16 Years
Eligibility 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.

Study Design


Intervention

Device:
Carriere Motion Appliance
Patient will be randomly allocated into two groups: Group I: conventional mandibular anchorage using passive lingual arch. Group II: anchorage by direct mini-screws. In the group I, Class II elastics will be attached from the maxillary canine to the mandibular first molar bilaterally with passive lingual arch in the lower arch as anchorage means. In the group I, Class II elastics will be attached from the maxillary canine to mandiular miniscrews bilaterally. For each patient, two CBCT radiographs will be obtained: one preoperatively and another after completion of distalization.

Locations

Country Name City State
Egypt Alazhar university Assiut

Sponsors (1)

Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Carriere L. A new Class II distalizer. J Clin Orthod. 2004 Apr;38(4):224-31. No abstract available. — View Citation

Rodriguez HL. Unilateral application of the Carriere Distalizer. J Clin Orthod. 2011 Mar;45(3):177-80. No abstract available. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment duration months from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)
Primary Skeletal changes degrees from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months) ]
Primary Dental changes degrees from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)
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