Malocclusion, Angle Class IINCT05499221
Bone Anchored Carriere Motion Appliance
A study testing Carriere motion appliance in people with Malocclusion, Angle Class II, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Angle Class II
- What is being tested?
- Carriere motion appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jan 2022to 26 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients age (11-16) 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.
Egypt1 site
MansouraU, faculty of dentistry, orthodontics department
Al Mansurah
About this study
Official title: Segmental Distalization by Bone Anchored Carriere Motion Appliance vs. Conventional One
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).
Read the 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.
- Conditions
- Malocclusion, Angle Class II
- Being tested
- Carriere motion appliance
- Keywords
- Carriere motion appliance, Distalization, Skeletal anchorage, Infrazygomatic miniscrews
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carriere motion applianceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional anchorage | Active comparator | 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. Receives: Device: Carriere motion appliance |
| Skeletal anchorage | Experimental | Closing coil springs will be attached from the maxillary canine to the infrazygomatic miniscrews bilaterally Receives: Device: Carriere motion appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment duration
months
Measured: from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)
Skeletal changes
degrees
Measured: from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)
Dental changes
degrees
Measured: from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start26 Jan 2022
- Primary completion26 Jun 2023
- Study completion26 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malocclusion, Angle Class IIStudies 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
- Model description
- Subjects will be randomly allocated into two groups: 1. Conventional anchorage CMA group (CAG): conventional mandibular anchorage using Essix retainer. 2. 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eglal Ahmed, Mansoura University
- Investigators
- Eglal A. Ghozy, BDS, MDS, Principal investigator, Mansoura UniversityAhmed A. El-bialy, PhD, Study chair, Mansoura UniversityMarwa S. Shamaa, PhD, Study director, Mansoura UniversityNehal F. Albelasy, PhD, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499221
- Sponsor's protocol ID
- A01040122
- Status last verified
- Jul 2024
- First submitted
- 5 Aug 2022
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ghozy EA, Albelasy NF, Shamaa MS, El-Bialy AA. Cephalometric and digital model analysis of dentoskeletal effects of infrazygomatic miniscrew vs. Essix- anchored Carriere Motion appliance for distalization of maxillary buccal segment: a randomized clinical trial. BMC Oral Health. 2024 Jan 31;24(1):152. doi: 10.1186/s12903-024-03925-3.
PubMed 38297285
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Segmental Distalization by Bone Anchored Carriere Motion Appliance vs. Conventional One
- ClinicalTrials.gov ID
- NCT05499221
- Acronym / sponsor ID
- A01040122
- Conditions
- Malocclusion, Angle Class II
- Keywords
- Carriere motion appliance, Distalization, Skeletal anchorage, Infrazygomatic miniscrews
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 26 Aug 2023 (actual)
- First posted
- 12 Aug 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomly allocated into two groups: 1. Conventional anchorage CMA group (CAG): conventional mandibular anchorage using Essix retainer. 2. 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional anchorage | Active comparator | Device: Carriere motion applianceBuccal 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. |
| Skeletal anchorage | Experimental | Device: Carriere motion applianceClosing coil springs will be attached from the maxillary canine to the infrazygomatic miniscrews bilaterally |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients age (11-16) 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 |
|---|---|---|
| Carriere motion applianceThe CMA will be bonded on the permanent maxillary canine and first molar, and the correct size is chosen according to the manufacturer's instructions. | Device | Conventional anchorage, Skeletal anchorage |
Primary outcome
Treatment duration
Time frame: from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)
months
Skeletal changes
Time frame: from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)
degrees
Dental changes
Time frame: from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)
degrees
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Derived from this study: PubMed 38297285Ghozy EA, Albelasy NF, Shamaa MS, El-Bialy AA. Cephalometric and digital model analysis of dentoskeletal effects of infrazygomatic miniscrew vs. Essix- anchored Carriere Motion appliance for distalization of maxillary buccal segment: a randomized clinical trial. BMC Oral Health. 2024 Jan 31;24(1):152. doi: 10.1186/s12903-024-03925-3.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Eglal A. Ghozy, BDS, MDS principal investigator
Mansoura University
Ahmed A. El-bialy, PhD study chair
Mansoura University
Marwa S. Shamaa, PhD study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carriere motion appliance in people with Malocclusion, Angle Class II, 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: finished, as of the sponsor's last update on 9 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment duration (time frame: from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05499221, which also lists 1 linked publication.
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 9 Jul 2024.