Ready-made vs. Custom-made Carriere Motion Appliance

January 14, 2026 updated by: Mansoura University

Ready-made vs. Custom-made Carriere Motion Appliance: A Randomized Clinical Trial

The aim of this study is to evaluate the effect of custom-made CMA vs. the ready-made CMA.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to evaluate the effect of custom-made CMA from brackets, buccal tubes, stiff wire, and NiTi coil springs and compare it with the ready-made CMA.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Adakhlia
      • Al Mansurah, Adakhlia, Egypt, 35511
        • Recruiting
        • Faculty of Dentistry, Mansoura University
        • Contact:
        • Principal Investigator:
          • Eglal A. Ghozy, PhD
        • Sub-Investigator:
          • Nehal F. Albelasy, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients age (12-15) 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Custom-made CMA
Custom-made CMA from brackets, buccal tubes, stiff wire, and NiTi coil springs
Device: Custom-made Carriere motion appliance
custom-made CMA from brackets, buccal tubes, stiff wire, and NiTi coil springs to treat class II malocclusion by molar distalization.
Active Comparator: Ready-made CMA
Device: Ready-made Carriere motion appliance
Ready-made Carriere motion appliance to treat class II malocclusion by molar distalization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment duration
Time Frame: up to 6 months from the start of treatment until the date of first documented progression
in about 6 months from the start of treatment till reaching class I molar relation
up to 6 months from the start of treatment until the date of first documented progression
Skeletal and dental changes
Time Frame: up to 6 months from the start of treatment until the date of first documented progression
angular and linear cephalometric measurements
up to 6 months from the start of treatment until the date of first documented progression

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft tissue changes
Time Frame: up to 6 months from the start of treatment until the date of first documented progression
angular and linear cephalometric measurements
up to 6 months from the start of treatment until the date of first documented progression
Patient satisfaction
Time Frame: up to 6 months from the start of treatment until the date of first documented progression
patient questionnaire about oral health related quality of life: their satisfaction and discomfort
up to 6 months from the start of treatment until the date of first documented progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2025

Primary Completion (Actual)

August 13, 2025

Study Completion (Estimated)

January 13, 2026

Study Registration Dates

First Submitted

August 10, 2025

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0101025OR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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