Class II MalocclusionNCT05166928
Effect of Upper Third Molar Extraction on Distalization Carriere Motion Appliance :A Prospective Clinical Study
A study testing carriere motion appliance in people with Class II Malocclusion, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This clinical study will be directed to compare the effect of presence or absence of third molar on distalization of the upper posterior segment by using carriere motion appliance Read more about this study
- Who is it for?
- Ages 14 to 22 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
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2021to Apr 2022
- 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 14 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Angle´s Class II canine relationship, at least half-unit.
- Skeletal Class I or mild Class II relationship.
- Upper second molars were fully erupted before starting distalization.
- Normal or horizontal growth pattern.
- Good oral hygiene.
- Absence of any systemic diseases
Who cannot join
- Previous orthodontic treatment. 2. Patients who required surgery to correct skeletal discrepancies (sever skeletal class11).
- 3. Patients with hyperdontia, hypodontia, or syndromic diseases. 4. Extraction or badly destructed teeth in upper arch
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Upper Third Molar Extraction on Distalization Using Carriere Motion Appliance :A Prospective Clinical Study
This clinical study will be directed to compare the effect of presence or absence of third molar on distalization of the upper posterior segment by using carriere motion appliance
- Conditions
- Class II Malocclusion
- Being tested
- 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
after finished treatment with carrirere motion appliance in the two group (group 1 have upper wisdom teeth ,group 2 have not upper wisdom teeth ) the pre and post casts will be scanned and superimposed to determine amount upper molar distalization
| Study group | Role | What they receive |
|---|---|---|
| group 1: control group | Active comparator | will be treated using carriere motion appliance for distalization of upper buccal segment in the presence of upper third molar Receives: Device: carriere motion appliance |
| group2: teste group | Active comparator | will be treated with using carriere motion appliance for distalization of upper buccal segment with upper third molar extraction or have congenital missing upper third molar Receives: Device: carriere motion appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in upper first molar position
using 3d cast superimposition
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start10 Jul 2021
- Primary completion10 Nov 2021
- Study completionApr 2022 (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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nassem mohsen qasem, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166928
- Sponsor's protocol ID
- 627/1151
- Status last verified
- Dec 2021
- First submitted
- 12 Dec 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Upper Third Molar Extraction on Distalization Using Carriere Motion Appliance :A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT05166928
- Acronym / sponsor ID
- 627/1151
- Conditions
- Class II Malocclusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- Apr 2022 (estimated)
- First posted
- 22 Dec 2021 (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.
This clinical study will be directed to compare the effect of presence or absence of third molar on distalization of the upper posterior segment by using carriere motion appliance
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1: control group | Active comparator | Device: carriere motion appliancewill be treated using carriere motion appliance for distalization of upper buccal segment in the presence of upper third molar |
| group2: teste group | Active comparator | Device: carriere motion appliancewill be treated with using carriere motion appliance for distalization of upper buccal segment with upper third molar extraction or have congenital missing upper third molar |
Who may qualify
- Ages
- 14 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Angle´s Class II canine relationship, at least half-unit.
- Skeletal Class I or mild Class II relationship.
- Upper second molars were fully erupted before starting distalization.
- Normal or horizontal growth pattern.
- Good oral hygiene.
Key exclusion criteria (3 listed)
- Previous orthodontic treatment. 2. Patients who required surgery to correct skeletal discrepancies (sever skeletal class11).
- 3. Patients with hyperdontia, hypodontia, or syndromic diseases. 4. Extraction or badly destructed teeth in upper arch
- -
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 applianceafter finished treatment with carrirere motion appliance in the two group (group 1 have upper wisdom teeth ,group 2 have not upper wisdom teeth ) the pre and post casts will be scanned and superimposed to determine amount upper molar distalization | Device | group 1: control group, group2: teste group |
Primary outcome
change in upper first molar position
Time frame: Baseline to 6 months
using 3d cast superimposition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Dec 2021. 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?
Results are not available in the source record.
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?
change in upper first molar position (time frame: Baseline to 6 months). 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 Dec 2021.