Class II MalocclusionNCT07361172
Ready-made vs. Custom-made Carriere Motion Appliance
A study testing Custom-made Carriere motion appliance and Ready-made Carriere motion appliance in people with Class II Malocclusion, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of custom-made CMA vs. the ready-made CMA. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Class II Malocclusion
- What is being tested?
- Custom-made Carriere motion appliance and Ready-made Carriere motion appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jan 2025to 13 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients age (12-15) years.
- Full permanent dentition.
- Class II malocclusion with at least an end-on Class II molar relationship bilaterally.
Who cannot join
- Systemic conditions that may interfere with the treatment.
- Bad habits that might jeopardize the appliance.
- Transverse discrepancy.
- Previous orthodontic treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Mansoura University
Al Mansurah, Adakhlia, 35511
Eglal A. Ghozy, PhD, 01121441414, eglalghozy@gmail.com
Eglal A. Ghozy, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Class II Malocclusion
- Being tested
- Custom-made Carriere motion appliance, Ready-made Carriere motion appliance
- Keywords
- Class II malocclusion, Carriere motion appliance, Distalization
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Ready-made Carriere motion applianceDevice
Ready-made Carriere motion appliance to treat class II malocclusion by molar distalization.
| Study group | Role | What they receive |
|---|---|---|
| Custom-made CMA | Experimental | Custom-made CMA from brackets, buccal tubes, stiff wire, and NiTi coil springs Receives: Device: Custom-made Carriere motion appliance |
| Ready-made CMA | Active comparator | Not described Receives: Device: Ready-made Carriere motion appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment duration
in about 6 months from the start of treatment till reaching class I molar relation
Measured: 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
Measured: up to 6 months from the start of treatment until the date of first documented progression
Secondary outcomes (2)
Soft tissue changes
angular and linear cephalometric measurements
Measured: up to 6 months from the start of treatment until the date of first documented progression
Patient satisfaction
patient questionnaire about oral health related quality of life: their satisfaction and discomfort
Measured: up to 6 months from the start of treatment until the date of first documented progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start13 Jan 2025
- Primary completion13 Aug 2025
- Study completion13 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361172
- Sponsor's protocol ID
- A0101025OR
- Status last verified
- May 2025
- First submitted
- 10 Aug 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ready-made vs. Custom-made Carriere Motion Appliance: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07361172
- Acronym / sponsor ID
- A0101025OR
- Conditions
- Class II Malocclusion
- Keywords
- Class II malocclusion, Carriere motion appliance, Distalization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 13 Jan 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effect of custom-made CMA vs. the ready-made CMA.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Custom-made CMA | Experimental | Device: Custom-made Carriere motion applianceCustom-made CMA from brackets, buccal tubes, stiff wire, and NiTi coil springs |
| Ready-made CMA | Active comparator | Device: Ready-made Carriere motion appliance |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients age (12-15) years.
- Full permanent dentition.
- Class II malocclusion with at least an end-on Class II molar relationship bilaterally.
Key exclusion criteria (4 listed)
- Systemic conditions that may interfere with the treatment.
- Bad habits that might jeopardize the appliance.
- Transverse discrepancy.
- Previous orthodontic treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custom-made Carriere motion appliancecustom-made CMA from brackets, buccal tubes, stiff wire, and NiTi coil springs to treat class II malocclusion by molar distalization. | Device | Custom-made CMA |
| Ready-made Carriere motion applianceReady-made Carriere motion appliance to treat class II malocclusion by molar distalization. | Device | Ready-made CMA |
Primary outcome
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
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
2 secondary outcomes
Soft tissue changes
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
Related trials for Class II Malocclusion
Recruiting
Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
Class II Malocclusion
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Recruiting
Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
Malocclusion, Class II Malocclusion
Recruiting
Treatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates
Malocclusion, Angle Class II
Recruiting
Patient-Reported Outcomes for Different Orthodontic Thermoplastics Used in Clear Aligners
Malocclusion of Anterior Teeth, Malocclusion in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom-made Carriere motion appliance and Ready-made Carriere motion appliance in people with Class II Malocclusion, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eglal A. Ghozy, PhD (+201121441414, eglalahmed@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment duration (time frame: up to 6 months from the start of treatment until the date of first documented progression). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.