Class II MalocclusionNCT05631353
TADs Anchored vs Conventional Anchored Carriere Motion Appliance
A study testing Carriere Motion Appliance in people with Class II Malocclusion, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Carriere Motion appliance (CMA) was designed to correct 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
- Class II Malocclusion
- 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
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Apr 2024
- 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
- Adolescent patients aged 11-17 years.
- Unilateral or bilateral Class II molar relationship.
- Bilateral Class II canine relationship.
- No history of previous orthodontic treatment.
- No malformed teeth, impacted teeth and unerupted teeth.
- No systemic disease.
Show all 10Show fewer
- Good oral hygiene.
- No abnormal pressure habit.
- No periodontal diseases.
- No missing teeth in maxillary arch.
Who cannot join
- The need for extraction in the lower arch.
- Posterior crossbite.
- Presence of any craniofacial anomalies.
- Patients with syndromes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carriere Motion Appliance in The Treatment of Class II Malocclusion Using Different Methods of Anchorage Control (Cone Beam Study)
Carriere Motion appliance (CMA) was designed to correct 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 revoke the adverse effects of CMA with class II elastics, we can use the CMA to distalize the maxillary posterior segment with TADs anchorage using miniscrews. The aim of this study is to evaluate TADs anchored CMA vs. conventionally anchored CMA for distalization of the maxillary buccal segment.
Read the detailed description
Twenty class II malocclusion patients with age (11-16) years will be randomly allocated in the two groups:
Group I: Patients will be treated by Carriere Motion Appliance using passive lingual arch.
Group II: Patients will be treated by Carriere Motion Appliance using direct mini-screw.
For each patient, two CBCT will be obtained: one preoperatively and another after completion of distalization.
Comparing skeletal and dental measurements obtained from CBCT radiographs obtained prior to treatment (T0) and immediately after correction of class II and remval of the appliance (T1).
- Conditions
- Class II Malocclusion
- Being tested
- Carriere Motion Appliance
- Keywords
- Carriere Motion Appliance
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carriere Motion ApplianceDevice
Also called Passive lingual arch., Mini-screw.
Patient will be randomly allocated into two groups:
Group I: conventional mandibular anchorage using passive lingual arch. Group II: anchorage by direct mini-screws. In the group I, Class II elastics will be attached from the maxillary canine to the mandibular first molar bilaterally with passive lingual arch in the lower arch as anchorage means.
In the group I, Class II elastics will be attached from the maxillary canine to mandiular miniscrews bilaterally.
For each patient, two CBCT radiographs will be obtained: one preoperatively and another after completion of distalization.
| Study group | Role | What they receive |
|---|---|---|
| Group I: Patients will be treated by Carriere Motion Appliance using passive lingual arch . | Active comparator | Conventional mandibular anchorage 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 |
| Group II: Patients will be treated by Carriere Motion Appliance using direct mini-screw. | Active comparator | TADs mandibular anchorage. 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 |
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 posted30 Nov 2022
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Class II MalocclusionStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelshafy Ali, Al-Azhar University
- Investigators
- Saleh Anwar El-sayed, professor, Study chair, saleh.anwar@azhar.edu.eg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631353
- Sponsor's protocol ID
- Carriere motion appliance
- Status last verified
- Jul 2024
- First submitted
- 21 Nov 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carriere L. A new Class II distalizer. J Clin Orthod. 2004 Apr;38(4):224-31. No abstract available.
PubMed 15115896Rodriguez HL. Unilateral application of the Carriere Distalizer. J Clin Orthod. 2011 Mar;45(3):177-80. No abstract available.
PubMed 21785202Wilson B, Konstantoni N, Kim KB, Foley P, Ueno H. Three-dimensional cone-beam computed tomography comparison of shorty and standard Class II Carriere Motion appliance. Angle Orthod. 2021 Jul 1;91(4):423-432. doi: 10.2319/041320-295.1.
PubMed 33560300
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carriere Motion Appliance in The Treatment of Class II Malocclusion Using Different Methods of Anchorage Control (Cone Beam Study)
- ClinicalTrials.gov ID
- NCT05631353
- Acronym / sponsor ID
- Carriere motion appliance
- Conditions
- Class II Malocclusion
- Keywords
- Carriere Motion Appliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 30 Nov 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 correct 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 revoke the adverse effects of CMA with class II elastics, we can use the CMA to distalize the maxillary posterior segment with TADs anchorage using miniscrews. The aim of this study is to evaluate TADs anchored CMA vs. conventionally anchored CMA for distalization of the maxillary buccal segment.
Detailed description
Twenty class II malocclusion patients with age (11-16) years will be randomly allocated in the two groups:
Group I: Patients will be treated by Carriere Motion Appliance using passive lingual arch.
Group II: Patients will be treated by Carriere Motion Appliance using direct mini-screw.
For each patient, two CBCT will be obtained: one preoperatively and another after completion of distalization.
Comparing skeletal and dental measurements obtained from CBCT radiographs obtained prior to treatment (T0) and immediately after correction of class II and remval of the appliance (T1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: Patients will be treated by Carriere Motion Appliance using passive lingual arch . | Active comparator | Device: Carriere Motion ApplianceConventional mandibular anchorage 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 |
| Group II: Patients will be treated by Carriere Motion Appliance using direct mini-screw. | Active comparator | Device: Carriere Motion ApplianceTADs mandibular anchorage. 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 |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Adolescent patients aged 11-17 years.
- Unilateral or bilateral Class II molar relationship.
- Bilateral Class II canine relationship.
- No history of previous orthodontic treatment.
- No malformed teeth, impacted teeth and unerupted teeth.
Key exclusion criteria (4 listed)
- The need for extraction in the lower arch.
- Posterior crossbite.
- Presence of any craniofacial anomalies.
- Patients with syndromes.
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 ApplianceAlso: Passive lingual arch., Mini-screw.Patient will be randomly allocated into two groups: Group I: conventional mandibular anchorage using passive lingual arch. Group II: anchorage by direct mini-screws. In the group I, Class II elastics will be attached from the maxillary canine to the mandibular first molar bilaterally with passive lingual arch in the lower arch as anchorage means. In the group I, Class II elastics will be attached from the maxillary canine to mandiular miniscrews bilaterally. For each patient, two CBCT radiographs will be obtained: one preoperatively and another after completion of distalization. | Device | Group I: Patients will be treated by Carriere Motion Appliance using passive lingual arch ., Group II: Patients will be treated by Carriere Motion Appliance using direct mini-screw. |
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 3 Jul 2024.
- Background: PubMed 15115896Carriere L. A new Class II distalizer. J Clin Orthod. 2004 Apr;38(4):224-31. No abstract available.
- Background: PubMed 21785202Rodriguez HL. Unilateral application of the Carriere Distalizer. J Clin Orthod. 2011 Mar;45(3):177-80. No abstract available.
- Background: PubMed 33560300Wilson B, Konstantoni N, Kim KB, Foley P, Ueno H. Three-dimensional cone-beam computed tomography comparison of shorty and standard Class II Carriere Motion appliance. Angle Orthod. 2021 Jul 1;91(4):423-432. doi: 10.2319/041320-295.1.
- 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.
Saleh Anwar El-sayed, professor study chair
saleh.anwar@azhar.edu.eg
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 Class II Malocclusion, run by Al-Azhar 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 10 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 3 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 NCT05631353, which also lists 3 linked publications.
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 3 Jul 2024.