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)
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2022
CompletedFirst Posted
Study publicly available on registry
November 30, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedJuly 3, 2024
July 1, 2024
1 year
November 21, 2022
July 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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)
Study Arms (2)
Group I: Patients will be treated by Carriere Motion Appliance using passive lingual arch .
ACTIVE COMPARATORConventional 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
Group II: Patients will be treated by Carriere Motion Appliance using direct mini-screw.
ACTIVE COMPARATORTADs 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- The need for extraction in the lower arch.
- Posterior crossbite.
- Presence of any craniofacial anomalies.
- Patients with syndromes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alazhar university
Asyut, Egypt
Related Publications (3)
Carriere L. A new Class II distalizer. J Clin Orthod. 2004 Apr;38(4):224-31. No abstract available.
PMID: 15115896BACKGROUNDRodriguez HL. Unilateral application of the Carriere Distalizer. J Clin Orthod. 2011 Mar;45(3):177-80. No abstract available.
PMID: 21785202BACKGROUNDWilson 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.
PMID: 33560300BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Saleh Anwar El-sayed, professor
saleh.anwar@azhar.edu.eg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- data will be sent blinded for statistical analysis
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
November 21, 2022
First Posted
November 30, 2022
Study Start
January 1, 2023
Primary Completion
January 1, 2024
Study Completion
April 1, 2024
Last Updated
July 3, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share