NCT07361172

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2025

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
Last Updated

January 22, 2026

Status Verified

May 1, 2025

Enrollment Period

7 months

First QC Date

August 10, 2025

Last Update Submit

January 14, 2026

Conditions

Class II Malocclusion

Keywords

Class II malocclusionCarriere motion applianceDistalization

Outcome Measures

Primary Outcomes (2)

  • Treatment duration

    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

    angular and linear cephalometric measurements

    up to 6 months from the start of treatment until the date of first documented progression

Secondary Outcomes (2)

  • Soft tissue changes

    up to 6 months from the start of treatment until the date of first documented progression

  • Patient satisfaction

    up to 6 months from the start of treatment until the date of first documented progression

Study Arms (2)

Custom-made CMA

EXPERIMENTAL

Custom-made CMA from brackets, buccal tubes, stiff wire, and NiTi coil springs

Device: Custom-made Carriere motion appliance

Ready-made CMA

ACTIVE COMPARATOR
Device: Ready-made Carriere motion appliance

Interventions

Ready-made Carriere motion applianceDEVICE

Ready-made Carriere motion appliance to treat class II malocclusion by molar distalization.

Ready-made CMA
Custom-made Carriere motion applianceDEVICE

custom-made CMA from brackets, buccal tubes, stiff wire, and NiTi coil springs to treat class II malocclusion by molar distalization.

Custom-made CMA

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients age (12-15) years.
  • Full permanent dentition.
  • Class II malocclusion with at least an end-on Class II molar relationship bilaterally.

You may not qualify if:

  • Systemic conditions that may interfere with the treatment.
  • Bad habits that might jeopardize the appliance.
  • Transverse discrepancy.
  • Previous orthodontic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Adakhlia, 35511, Egypt

RECRUITING

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class IIMalocclusionTooth DiseasesStomatognathic Diseases

Central Study Contacts

Eglal A. Ghozy, PhD

CONTACT

+201121441414eglalahmed@mans.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2025

First Posted

January 22, 2026

Study Start

January 13, 2025

Primary Completion

August 13, 2025

Study Completion

January 13, 2026

Last Updated

January 22, 2026

Record last verified: 2025-05

Locations

EG(1)