TADs Anchored vs Conventional Anchored Carriere Motion Appliance

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

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.

Study Overview

• Status: Completed
• Conditions: Class II Malocclusion
• Intervention / Treatment: Device: Carriere Motion Appliance

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Alazhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I: Patients will be treated by Carriere Motion Appliance using passive lingual arch .; 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	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.; Other Names: Passive lingual arch.; Mini-screw.
Active Comparator: Group II: Patients will be treated by Carriere Motion Appliance using direct mini-screw.; 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	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.; Other Names: Passive lingual arch.; Mini-screw.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Chair: Saleh Anwar El-sayed, professor, saleh.anwar@azhar.edu.eg

Publications and helpful links

General Publications

• Carriere L. A new Class II distalizer. J Clin Orthod. 2004 Apr;38(4):224-31. No abstract available.
• Rodriguez HL. Unilateral application of the Carriere Distalizer. J Clin Orthod. 2011 Mar;45(3):177-80. No abstract available.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Carriere Motion Appliance
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite
• Other Study ID Numbers: Carriere motion appliance

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No