Mandibular PrognathismNCT04629859
Orthognathic Surgeries and Pharyngeal Airway Space
A study testing mandibular setback and maxillary advancement and mandibular setback in people with Mandibular Prognathism, run by Fayoum University at 1 site in Egypt.
Trial summary
twenty-four patients with dentoskeletal deformity of class III will be divided equally into two groups and will be subjected to orthognathic surgeries group A; will be treated by mandibular setback surgery while group B will be treated with bimaxillary orthognathic surgery in the form of mandibular setback and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mandibular Prognathism
- What is being tested?
- mandibular setback and maxillary advancement and mandibular setback
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dento-skeletal class III malocclusion which needed a surgical intervention with maxillary advancement surgery and/or mandibular set-back orthognathic surgery in the form of bilateral sagittal split osteotomy
- no previous orthognathic surgery
Who cannot join
- Patients with craniofacial syndromes.
- Medically compromised patients and patients with bone anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Malocclusion Patients
twenty-four patients with dentoskeletal deformity of class III will be divided equally into two groups and will be subjected to orthognathic surgeries group A; will be treated by mandibular setback surgery while group B will be treated with bimaxillary orthognathic surgery in the form of mandibular setback and maxillary advancement surgeries. the total pharyngeal airway will be measured on lateral cephalometric radiographs, integrating retro-palatal and retro-glossal area, and statistically will be compared preoperative, immediate postoperative, and at 6 months post-surgically
- Conditions
- Mandibular Prognathism
- Being tested
- mandibular setback and maxillary advancement, mandibular setback
- Keywords
- Orthognathic surgery, Pharyngeal airway space, skeletal class III patients.
- Medical subject headings
- Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mandibular setback and maxillary advancementProcedure or surgery
12 patients will undergo mandibular setback and maxillary advancement
mandibular setbackProcedure or surgery
12 patients will undergo mandibular setback
| Study group | Role | What they receive |
|---|---|---|
| study arm | Experimental | dento skeletal class III patients will undergo a mandibular setback surgery and maxillary advancement Receives: Procedure: mandibular setback and maxillary advancement |
| controlled arm | Experimental | dento skeletal class III patients will undergo a mandibular setback surgery Receives: Procedure: mandibular setback |
What is being measured
The primary outcome is the main question the study is designed to answer.
total pharyngeal airway space surface area
Cephalometric analyses will be performed, the pharyngeal airway is demarcated inferiorly by a line passing through the tip of epiglottis and the superior tip of the hyoid bone, namely Line A, while the retro-glossal and the retro-palatal airway is separated by a line extending from the basion parallel to line A.
All the reference points and lines were conveyed to the images . The Pharyngeal airway space was measured and compared.
Measured: 6 months
Secondary outcomes (1)
Epworth sleepiness scale
(0-24) score to assess sleep apnea indirect
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 posted16 Nov 2020
- Study start1 Jan 2020
- Primary completion30 Nov 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular PrognathismStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohsen, Fayoum University
- Investigators
- hussien hatem, phd, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629859
- Sponsor's protocol ID
- 12/10/19
- Status last verified
- Aug 2023
- First submitted
- 11 Nov 2020
- Last updated
- 7 Aug 2023
- 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 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malocclusion Patients
- ClinicalTrials.gov ID
- NCT04629859
- Acronym / sponsor ID
- 12/10/19
- Conditions
- Mandibular Prognathism
- Keywords
- Orthognathic surgery, Pharyngeal airway space, skeletal class III patients.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 16 Nov 2020 (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.
twenty-four patients with dentoskeletal deformity of class III will be divided equally into two groups and will be subjected to orthognathic surgeries group A; will be treated by mandibular setback surgery while group B will be treated with bimaxillary orthognathic surgery in the form of mandibular setback and maxillary advancement surgeries. the total pharyngeal airway will be measured on lateral cephalometric radiographs, integrating retro-palatal and retro-glossal area, and statistically will be compared preoperative, immediate postoperative, and at 6 months post-surgically
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study arm | Experimental | Procedure: mandibular setback and maxillary advancementdento skeletal class III patients will undergo a mandibular setback surgery and maxillary advancement |
| controlled arm | Experimental | Procedure: mandibular setbackdento skeletal class III patients will undergo a mandibular setback surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- dento-skeletal class III malocclusion which needed a surgical intervention with maxillary advancement surgery and/or mandibular set-back orthognathic surgery in the form of bilateral sagittal split osteotomy
- no previous orthognathic surgery
Key exclusion criteria (2 listed)
- Patients with craniofacial syndromes.
- Medically compromised patients and patients with bone anomalies
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 |
|---|---|---|
| mandibular setback and maxillary advancement12 patients will undergo mandibular setback and maxillary advancement | Procedure or surgery | study arm |
| mandibular setback12 patients will undergo mandibular setback | Procedure or surgery | controlled arm |
Primary outcome
total pharyngeal airway space surface area
Time frame: 6 months
Cephalometric analyses will be performed, the pharyngeal airway is demarcated inferiorly by a line passing through the tip of epiglottis and the superior tip of the hyoid bone, namely Line A, while the retro-glossal and the retro-palatal airway is separated by a line extending from the basion parallel to line A. All the reference points and lines were conveyed to the images . The Pharyngeal airway space was measured and compared.
1 secondary outcome
Epworth sleepiness scale
Time frame: 6 months
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 7 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Mandibular Prognathism
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Natural History of Craniofacial Anomalies and Developmental Growth Variants
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Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children
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Nano Coated Orthodontic Miniscrews for en Mass Retraction of the Upper Arch
Class I Malocclusion, Maxillary Prognathism
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Facial Conformation Meshes for Orthognathic Surgery
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Incidence of Body Dysmorphic Disorder (BDD) in a Population of Patients Undergoing Orthognathic Surgery
Orthognathic Surgical Procedures, Psychiatric Disorders
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.
hussien hatem, phd study director
Cairo 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 mandibular setback and maxillary advancement and mandibular setback in people with Mandibular Prognathism, run by Fayoum 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 2 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: finished, as of the sponsor's last update on 7 Aug 2023. 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?
total pharyngeal airway space surface area (time frame: 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 7 Aug 2023.