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TADs Anchored vs Conventional Anchored Carriere Motion Appliance

Primary Purpose

Class II Malocclusion

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Carriere Motion Appliance
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Malocclusion focused on measuring Carriere Motion Appliance

Eligibility Criteria

11 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Alazhar university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

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.

Arm Description

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

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

Outcomes

Primary Outcome Measures

Treatment duration
months
Skeletal changes
degrees
Dental changes
degrees

Secondary Outcome Measures

Full Information

First Posted
November 21, 2022
Last Updated
November 21, 2022
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05631353
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Malocclusion
Keywords
Carriere Motion Appliance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
data will be sent blinded for statistical analysis
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I: Patients will be treated by Carriere Motion Appliance using passive lingual arch .
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group II: Patients will be treated by Carriere Motion Appliance using direct mini-screw.
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Carriere Motion Appliance
Other Intervention Name(s)
Passive lingual arch., Mini-screw.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment duration
Description
months
Time Frame
from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)
Title
Skeletal changes
Description
degrees
Time Frame
from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months) ]
Title
Dental changes
Description
degrees
Time Frame
from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdelshafy Ali Megahed, PHD
Phone
00201099353710
Email
abdelshafy.dentist@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Saleh Saad Abd El-Ghafar, lecturer
Phone
00201001996884
Email
ibrahemsaad1114@azhar.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saleh Anwar El-sayed, professor
Organizational Affiliation
saleh.anwar@azhar.edu.eg
Official's Role
Study Chair
Facility Information:
Facility Name
Alazhar university
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15115896
Citation
Carriere L. A new Class II distalizer. J Clin Orthod. 2004 Apr;38(4):224-31. No abstract available.
Results Reference
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PubMed Identifier
21785202
Citation
Rodriguez HL. Unilateral application of the Carriere Distalizer. J Clin Orthod. 2011 Mar;45(3):177-80. No abstract available.
Results Reference
background
PubMed Identifier
33560300
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.
Results Reference
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TADs Anchored vs Conventional Anchored Carriere Motion Appliance

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