AirwayNCT06197880
Airway Morphology After En-masse Retraction in Bimaxillary Protrusion Patients
A study testing Anterior teeth retraction in people with Airway, run by Beni-Suef University at 1 site in Egypt.
Trial summary
This study aims to three-dimensionally assess the changes in the airway morphology after anterior segment retraction using maximum anchorage. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Airway
- What is being tested?
- Anterior teeth retraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2022to 1 Feb 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Class I bimaxillary protrusion requiring extraction of four first premolars and en masse retraction of the anterior segments.
- Age: 18 - 35 years old.
- Fair oral hygiene.
Who cannot join
- Active periodontal disease.
- Systemic diseases or medications that alter bone metabolism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three-dimensional Evaluation of the Airway Morphology After En-masse Retraction in Bimaxillary Protrusion Patients by Using Cone Beam Computed Tomography
This study aims to three-dimensionally assess the changes in the airway morphology after anterior segment retraction using maximum anchorage.
Read the detailed description
Participants were recruited from the Faculty of Dentistry, Beni-Suef University. All subjects were informed of the treatment procedures and signed a consent form.
Methodology:
The patients were treated by using fixed appliance and extraction of four first premolars. Maximum anchorage was obtained by using miniscrews that were inserted between the maxillary first molars and second premolars. En masse retraction of the upper and lower anterior segments was carried out by using NiTi closed coil springs.
Cone beam computed tomography (CBCT) will be obtained before (T0) and after en masse retraction (T1). CBCT will be used for three-dimensional evaluation of the changes of the airway morphology after en masse retraction of the upper and lower anterior segments with maximum anchorage.
The results will be obtained and statistically evaluated.
- Conditions
- Airway
- Being tested
- Anterior teeth retraction
- Keywords
- en-masse retraction airway morphology CBCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior teeth retractionOther
En masse retraction of the upper and lower anterior segments using maximum anchorage
| Study group | Role | What they receive |
|---|---|---|
| Bimaxillary protrusion | Experimental | En masse retraction Receives: Other: Anterior teeth retraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the changes in the airway morphology
measure the airway volume before and after treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start20 Jul 2022
- Primary completion15 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
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 AirwayStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Model description
- single-arm clinical trial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Abd El Razek Abd El Aziz Khalil, Beni-Suef University
- Investigators
- Rehab Khalil, Principal investigator, Faculty of Dentistry Beni Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197880
- Sponsor's protocol ID
- # REC-FDBSU/07072022-01/AR
- Status last verified
- Dec 2023
- First submitted
- 26 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valiathan M, El H, Hans MG, Palomo MJ. Effects of extraction versus non-extraction treatment on oropharyngeal airway volume. Angle Orthod. 2010 Nov;80(6):1068-74. doi: 10.2319/010810-19.1.
PubMed 20677956Wang Q, Jia P, Anderson NK, Wang L, Lin J. Changes of pharyngeal airway size and hyoid bone position following orthodontic treatment of Class I bimaxillary protrusion. Angle Orthod. 2012 Jan;82(1):115-21. doi: 10.2319/011011-13.1. Epub 2011 Jul 27.
PubMed 21793712Chen Y, Hong L, Wang CL, Zhang SJ, Cao C, Wei F, Lv T, Zhang F, Liu DX. Effect of large incisor retraction on upper airway morphology in adult bimaxillary protrusion patients. Angle Orthod. 2012 Nov;82(6):964-70. doi: 10.2319/110211-675.1. Epub 2012 Mar 30.
PubMed 22462464
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Evaluation of the Airway Morphology After En-masse Retraction in Bimaxillary Protrusion Patients by Using Cone Beam Computed Tomography
- ClinicalTrials.gov ID
- NCT06197880
- Acronym / sponsor ID
- # REC-FDBSU/07072022-01/AR
- Conditions
- Airway
- Keywords
- en-masse retraction airway morphology CBCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 9 Jan 2024 (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 study aims to three-dimensionally assess the changes in the airway morphology after anterior segment retraction using maximum anchorage.
Detailed description
Participants were recruited from the Faculty of Dentistry, Beni-Suef University. All subjects were informed of the treatment procedures and signed a consent form.
Methodology:
The patients were treated by using fixed appliance and extraction of four first premolars. Maximum anchorage was obtained by using miniscrews that were inserted between the maxillary first molars and second premolars. En masse retraction of the upper and lower anterior segments was carried out by using NiTi closed coil springs.
Cone beam computed tomography (CBCT) will be obtained before (T0) and after en masse retraction (T1). CBCT will be used for three-dimensional evaluation of the changes of the airway morphology after en masse retraction of the upper and lower anterior segments with maximum anchorage.
The results will be obtained and statistically evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| Bimaxillary protrusion | Experimental | Other: Anterior teeth retractionEn masse retraction |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Class I bimaxillary protrusion requiring extraction of four first premolars and en masse retraction of the anterior segments.
- Age: 18 - 35 years old.
- Fair oral hygiene.
Key exclusion criteria (2 listed)
- Active periodontal disease.
- Systemic diseases or medications that alter bone metabolism.
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 |
|---|---|---|
| Anterior teeth retractionEn masse retraction of the upper and lower anterior segments using maximum anchorage | Other | Bimaxillary protrusion |
Primary outcome
assess the changes in the airway morphology
Time frame: 6 months
measure the airway volume before and after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Background: PubMed 20677956Valiathan M, El H, Hans MG, Palomo MJ. Effects of extraction versus non-extraction treatment on oropharyngeal airway volume. Angle Orthod. 2010 Nov;80(6):1068-74. doi: 10.2319/010810-19.1.
- Background: PubMed 21793712Wang Q, Jia P, Anderson NK, Wang L, Lin J. Changes of pharyngeal airway size and hyoid bone position following orthodontic treatment of Class I bimaxillary protrusion. Angle Orthod. 2012 Jan;82(1):115-21. doi: 10.2319/011011-13.1. Epub 2011 Jul 27.
- Background: PubMed 22462464Chen Y, Hong L, Wang CL, Zhang SJ, Cao C, Wei F, Lv T, Zhang F, Liu DX. Effect of large incisor retraction on upper airway morphology in adult bimaxillary protrusion patients. Angle Orthod. 2012 Nov;82(6):964-70. doi: 10.2319/110211-675.1. Epub 2012 Mar 30.
- 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.
Rehab Khalil principal investigator
Faculty of Dentistry Beni Suef 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 Anterior teeth retraction in people with Airway, run by Beni-Suef 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 2 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 9 Jan 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?
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?
assess the changes in the airway morphology (time frame: 6 months). 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 NCT06197880, 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 9 Jan 2024.