Orthodontic ApplianceCBCTNCT05261217
Three-Dimensional Evaluation of the Airway Space After Distalization in Adults Using Carrière Motion Appliance
A study testing The motion 3D II appliance in people with Orthodontic Appliance, run by Suez Canal University at 1 site in Egypt.
Trial summary
Class II malocclusion is quite possibly most continuous treatment issues confronting orthodontists, addressing just about 33% malocclusions. connection between II malocclusion decreased pharyngeal aviation route measurements has been accounted for in writing. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Orthodontic Appliance
- What is being tested?
- The motion 3D II appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Dec 2019to 20 Mar 2021
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Dental II malocclusion beginning from half unit three quarter unit II relationship reciprocally where treatment plan did exclude extraction in upper curve.
- A ordinary skeletal maxilla typical or gentle direct retrognathic mandible. Normal or flat development design. All patients ought have great oral cleanliness ought consent inspiration directions give sensible forecast.
- Absence ejected maxillary third molars. The patients should be liberated from any foundational illness or medical conditions.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three-Dimensional Evaluation of the Airway Space After Distalization in Adults Using Carrière Motion Appliance: Cone Beam Computed Tomographic Study
Class II malocclusion is quite possibly most continuous treatment issues confronting orthodontists, addressing just about 33% malocclusions. connection between II malocclusion decreased pharyngeal aviation route measurements has been accounted for in writing. few treatment alternatives have been endeavored address this malocclusion, one those choices is distalize maxillary back without extraction treatment. In 2004 another machine presented Luis Carrière conveying his name, called Carrière Motion apparatus. Nonetheless, so far RCT in orthodontic writing assessed impact this machine elements aviation route.
The point this examination assess impact this machine upper aviation route CBCT pictures in treatment post-pubertal patiets dental II malocclusion. near report led comprising 18 members age range from 18-30 years age. treatment impacts assessed radiographically utilizing pre post-distalization CBCT pictures after I connection has been reached. three dimentional investigation performed contemplate impacts distalization upper aviation route. gathered information then genuinely broke down for treatment changes among pre post-distalization.
Read the detailed description
Patients selected from outpatient center at Department Orthodontics, Faculty Oral Dental Medicine, Suez Canal University. Research Ethical Committee Faculty Oral Dental Medicine, Suez Canal University endorsed this investigation. Patients educated about methodology shown logical, enlivened recordings.
- Incorporation standards:
The chose patients had met accompanying models:
- Adults full lasting dentition matured from (18-30). b) Dental II malocclusion beginning from half unit three quarter unit II relationship reciprocally where treatment plan did exclude extraction in upper curve.
- A ordinary skeletal maxilla typical or gentle direct retrognathic mandible. d) Normal or flat development design. e) All patients ought have great oral cleanliness ought consent inspiration directions give sensible forecast.
- Absence ejected maxillary third molars. g) The patients should be liberated from any foundational illness or medical conditions.
- Prohibition models:
- Patients set experiences any genuine injury or medical procedure orofacial district.
- sex inclination.
- No history orthodontic treatment subjects.
- No history obstructive breathing issues. 5-Methodology: 5.1 Preoperative intercession:
A Medical History Questionnaire:
A clinical filled patients bar any patients who might be experience ill effects any fundamental illness. Besides, patients checked ear nose throat expert affirm shortfall any aviation route problem.
5.2 Dental Case History Clinical Examination: A total dental case history acquired from every quiet patients analyzed clinically submitted both extraoral intraoral assessment. patients checked meet incorporation measures recently referenced. chose patients who met rules, alluded Periodontal Department centers for additional improvement oral cleanliness Restorative Department Clinics for any necessary fillings lastly alluded Oral Maxillofacial Surgery Department for extraction third maxillary molars in case they completely ejected in oral cavity.
5.3 Patients' Records: The accompanying records acquired from every understanding before endless supply treatment time, 5.3.1 Photographs For every tolerant bunch 4 extraoral 5 intraoral photos taken 5.3.2 Orthodontic Study Models All patients submitted upper lower impressions utilizing alginate impressionA material. wax wafer chomp additionally acquired. Impressions poured promptly utilizing extra hard stone model bases appropriately framed managed orthodontic norms 5.3.3 Cone Beam Computed Tomography: The chose patients submitted two CBCT examines; one pre-usable another after finish distalization utilizing Carrière Motion machine. CBCT pictures procured utilizing SOREDEX SCANORA 3D present in radiology office in Faculty Dentistry Suez Canal University. CBCT examining is performed producer's convention similar administrator. boundaries CBCT set suggestion assembling
- Conditions
- Orthodontic Appliance
- Being tested
- The motion 3D II appliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The motion 3D II applianceDevice
The motion 3D II appliance treating class II malocclusion
| Study group | Role | What they receive |
|---|---|---|
| The motion 3D II appliance | Experimental | using The motion 3D II appliance on treating Class II orthodontic Receives: Device: The motion 3D II appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cone Beam Computed Tomography
CBCT with Nasopharyngeal Airway Nasopharyngeal Airway Volume Oropharyngeal Airway
Oropharyngeal Airway volume Hypopharyngeal Airway Hypopharyngeal Airway volume parameters
Measured: nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start18 Dec 2019
- Primary completion15 Mar 2021
- Study completion20 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic ApplianceStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Allah Ahmed Ahmed ELghawy, Suez Canal University
- Investigators
- Heba Allah ELghawy, Bachlor, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261217
- Sponsor's protocol ID
- 192/2019
- Acronym
- CBCT
- Status last verified
- Feb 2022
- First submitted
- 19 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Dimensional Evaluation of the Airway Space After Distalization in Adults Using Carrière Motion Appliance: Cone Beam Computed Tomographic Study
- ClinicalTrials.gov ID
- NCT05261217
- Acronym / sponsor ID
- CBCT / 192/2019
- Conditions
- Orthodontic Appliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 2 Mar 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.
Class II malocclusion is quite possibly most continuous treatment issues confronting orthodontists, addressing just about 33% malocclusions. connection between II malocclusion decreased pharyngeal aviation route measurements has been accounted for in writing. few treatment alternatives have been endeavored address this malocclusion, one those choices is distalize maxillary back without extraction treatment. In 2004 another machine presented Luis Carrière conveying his name, called Carrière Motion apparatus. Nonetheless, so far RCT in orthodontic writing assessed impact this machine elements aviation route.
The point this examination assess impact this machine upper aviation route CBCT pictures in treatment post-pubertal patiets dental II malocclusion. near report led comprising 18 members age range from 18-30 years age. treatment impacts assessed radiographically utilizing pre post-distalization CBCT pictures after I connection has been reached. three dimentional investigation performed contemplate impacts distalization upper aviation route. gathered information then genuinely broke down for treatment changes among pre post-distalization.
Detailed description
Patients selected from outpatient center at Department Orthodontics, Faculty Oral Dental Medicine, Suez Canal University. Research Ethical Committee Faculty Oral Dental Medicine, Suez Canal University endorsed this investigation. Patients educated about methodology shown logical, enlivened recordings.
- Incorporation standards:
The chose patients had met accompanying models:
- Adults full lasting dentition matured from (18-30). b) Dental II malocclusion beginning from half unit three quarter unit II relationship reciprocally where treatment plan did exclude extraction in upper curve.
- A ordinary skeletal maxilla typical or gentle direct retrognathic mandible. d) Normal or flat development design. e) All patients ought have great oral cleanliness ought consent inspiration directions give sensible forecast.
- Absence ejected maxillary third molars. g) The patients should be liberated from any foundational illness or medical conditions.
- Prohibition models:
- Patients set experiences any genuine injury or medical procedure orofacial district.
- sex inclination.
- No history orthodontic treatment subjects.
- No history obstructive breathing issues. 5-Methodology: 5.1 Preoperative intercession:
A Medical History Questionnaire:
A clinical filled patients bar any patients who might be experience ill effects any fundamental illness. Besides, patients checked ear nose throat expert affirm shortfall any aviation route problem.
5.2 Dental Case History Clinical Examination: A total dental case history acquired from every quiet patients analyzed clinically submitted both extraoral intraoral assessment. patients checked meet incorporation measures recently referenced. chose patients who met rules, alluded Periodontal Department centers for additional improvement oral cleanliness Restorative Department Clinics for any necessary fillings lastly alluded Oral Maxillofacial Surgery Department for extraction third maxillary molars in case they completely ejected in oral cavity.
5.3 Patients' Records: The accompanying records acquired from every understanding before endless supply treatment time, 5.3.1 Photographs For every tolerant bunch 4 extraoral 5 intraoral photos taken 5.3.2 Orthodontic Study Models All patients submitted upper lower impressions utilizing alginate impressionA material. wax wafer chomp additionally acquired. Impressions poured promptly utilizing extra hard stone model bases appropriately framed managed orthodontic norms 5.3.3 Cone Beam Computed Tomography: The chose patients submitted two CBCT examines; one pre-usable another after finish distalization utilizing Carrière Motion machine. CBCT pictures procured utilizing SOREDEX SCANORA 3D present in radiology office in Faculty Dentistry Suez Canal University. CBCT examining is performed producer's convention similar administrator. boundaries CBCT set suggestion assembling
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The motion 3D II appliance | Experimental | Device: The motion 3D II applianceusing The motion 3D II appliance on treating Class II orthodontic |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Dental II malocclusion beginning from half unit three quarter unit II relationship reciprocally where treatment plan did exclude extraction in upper curve.
- A ordinary skeletal maxilla typical or gentle direct retrognathic mandible. Normal or flat development design. All patients ought have great oral cleanliness ought consent inspiration directions give sensible forecast.
- Absence ejected maxillary third molars. The patients should be liberated from any foundational illness or medical conditions.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| The motion 3D II applianceThe motion 3D II appliance treating class II malocclusion | Device | The motion 3D II appliance |
Primary outcome
Cone Beam Computed Tomography
Time frame: nine months
CBCT with Nasopharyngeal Airway Nasopharyngeal Airway Volume Oropharyngeal Airway Oropharyngeal Airway volume Hypopharyngeal Airway Hypopharyngeal Airway volume parameters
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 2 Mar 2022.
- 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.
Heba Allah ELghawy, Bachlor principal investigator
Suez Canal 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 The motion 3D II appliance in people with Orthodontic Appliance, run by Suez Canal 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 1 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 2 Mar 2022. 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?
Cone Beam Computed Tomography (time frame: nine 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 2 Mar 2022.