search
Back to results

Bone Anchored Carriere Motion Appliance

Primary Purpose

Malocclusion, Angle Class II

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Carriere motion appliance
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion, Angle Class II focused on measuring Carriere motion appliance, Distalization, Skeletal anchorage, Infrazygomatic miniscrews

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients age (11-16) years.
  2. Full permanent dentition.
  3. Class II malocclusion with at least an end-on Class II molar relationship bilaterally.

Exclusion Criteria:

  1. Systemic conditions that may interfere with the treatment.
  2. Bad habits that might jeopardize the appliance.
  3. Transverse discrepancy.
  4. Previous orthodontic treatment.

Sites / Locations

  • MansouraU, faculty of dentistry, orthodontics departmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional anchorage

Skeletal anchorage

Arm Description

Buccal tubes will be bonded on the lower first molars, an alginate impression will be taken for the lower arch with the buccal tubes in place, and a cast will be poured. A hard vacuum sheet of 1.5- mm thickness will be used to fabricate the Essix appliance. The posterior end of the buccal surface will be trimmed in each lower first molar region, creating a window to allow for attachment of the elastics. Class II elastics will be attached from the maxillary canine to the mandibular first molar bilaterally. 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.

Closing coil springs will be attached from the maxillary canine to the infrazygomatic miniscrews bilaterally

Outcomes

Primary Outcome Measures

Treatment duration
months
Skeletal changes
degrees
Dental changes
degrees

Secondary Outcome Measures

Full Information

First Posted
August 5, 2022
Last Updated
August 10, 2022
Sponsor
Mansoura University
search

1. Study Identification

Unique Protocol Identification Number
NCT05499221
Brief Title
Bone Anchored Carriere Motion Appliance
Official Title
Segmental Distalization by Bone Anchored Carriere Motion Appliance vs. Conventional One
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 26, 2022 (Actual)
Primary Completion Date
June 26, 2023 (Anticipated)
Study Completion Date
October 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
Carriere Motion appliance (CMA) was designed to change 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 eliminate the adverse effects of CMA with class II elastics, we can use the CMA to distalize the maxillary posterior segment with intra-arch anchorage using infrazygomatic miniscrews. The aim of this study is to evaluate skeletaly anchored CMA for distalization of the maxillary buccal segment vs. conventionally anchored CMA by comparing skeletal and dental measurements obtained from lateral cephalometric radiographs obtained prior to treatment (T0) and immediately after correction of class II and remval of the appliance (T1).
Detailed Description
Thirty-two class II malocclusion patients with age (11-16) years will be randomly allocated in the two groups: Conventional anchorage CMA group (CAG): conventional mandibular anchorage using Essix retainer. Skeletal anchorage CMA group (SAG): anchorage by infra-zygomatic miniscrews. In the CAG, Class II elastics will be attached from the maxillary canine to the mandibular first molar bilaterally with Essix retainer in the lower arch as anchorage means. In the SAG, closing coil spring will be attached from the maxillary canine to the infrazygomatic miniscrews bilaterally. For each patient, two lateral cephalograms will be obtained: one preoperatively and another after completion of distalization. Model measurements will be made using the attached 3Shape computer software.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class II
Keywords
Carriere motion appliance, Distalization, Skeletal anchorage, Infrazygomatic miniscrews

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomly allocated into two groups: Conventional anchorage CMA group (CAG): conventional mandibular anchorage using Essix retainer. Skeletal anchorage CMA group (SAG): anchorage by infra-zygomatic mini-screws. In the CAG, Class II elastics will be attached from the maxillary canine to the mandibular first molar bilaterally with Essix retainer in the lower arch as anchorage means. In the SAG, the closing coil spring will be attached from the maxillary canine to the infra zygomatic miniscrews bilaterally. For each patient, two lateral cephalograms will be obtained: one preoperatively and another after completion of distalization. Model measurements will be made using the attached 3Shape computer software.
Masking
Outcomes Assessor
Masking Description
data will be sent blinded for statistical analysis
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional anchorage
Arm Type
Active Comparator
Arm Description
Buccal tubes will be bonded on the lower first molars, an alginate impression will be taken for the lower arch with the buccal tubes in place, and a cast will be poured. A hard vacuum sheet of 1.5- mm thickness will be used to fabricate the Essix appliance. The posterior end of the buccal surface will be trimmed in each lower first molar region, creating a window to allow for attachment of the elastics. Class II elastics will be attached from the maxillary canine to the mandibular first molar bilaterally. 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
Skeletal anchorage
Arm Type
Experimental
Arm Description
Closing coil springs will be attached from the maxillary canine to the infrazygomatic miniscrews bilaterally
Intervention Type
Device
Intervention Name(s)
Carriere motion appliance
Intervention Description
The CMA will be bonded on the permanent maxillary canine and first molar, and the correct size is chosen according to the manufacturer's instructions.
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: Patients age (11-16) years. Full permanent dentition. Class II malocclusion with at least an end-on Class II molar relationship bilaterally. Exclusion Criteria: Systemic conditions that may interfere with the treatment. Bad habits that might jeopardize the appliance. Transverse discrepancy. Previous orthodontic treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eglal A. Ghozy, BDS, MDs
Phone
00201121441414
Email
eglalahmed@mans.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed A. El-Bialy, PhD
Phone
00201002200017
Email
bialy@doctor.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eglal A. Ghozy, BDS, MDS
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed A. El-bialy, PhD
Organizational Affiliation
Mansoura University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marwa S. Shamaa, PhD
Organizational Affiliation
Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nehal F. Albelasy, PhD
Organizational Affiliation
Mansoura University
Official's Role
Study Director
Facility Information:
Facility Name
MansouraU, faculty of dentistry, orthodontics department
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eglal A. Ghozy, BDS, MDS

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Bone Anchored Carriere Motion Appliance

We'll reach out to this number within 24 hrs