Maxillofacial AbnormalitiesNCT05713084
Condylar Position Changes and TMJ Functions After BSSO Mandibular Setback, Low Medial Cut.
A study testing mandibular setback using BSSRO in people with Maxillofacial Abnormalities and Mandible Prognathism, run by Cairo University at 1 site in Egypt.
Trial summary
This study hypotheses that using low medial cut osteotomy BSSO in mandibular setback can be an efficient and effective method to limit the bony segment interferences , decreasing muscles stripping during osteotomy ,decrease condylar torque and so securing preoperative condylar position during BSSO in comparison with… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillofacial Abnormalities, Mandible Prognathism, Skeletal Malocclusion
- What is being tested?
- mandibular setback using BSSRO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Sep 2022to Sep 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age of the patient between (18-60) years
- Patients in need of mandibular setback using bilateral sagittal split osteotomy.
- All patients are free from any systemic disease that may affect normal bone healing.
- Patient with facial deformity will be treated with mandibular setback either mono or bimaxilary surgeries
- Patient with facial deformity will be treated with mandibular setback either surgery first approach or orthofirst approach.
- Sufficient dentition to reproduce the occlusal relationships
- Patient's consent to participate
Who cannot join
- Patients with any systemic disease that may affect normal healing
- Intra-bony lesions or infections that may interfere with surgery.
- Previous orthognathic surgeries.
- Patients with all types of facial clefts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Condylar Position Changes and TMJ Functions After BSSO Mandibular Setback, Low Medial vs High Medial Cut (Randomized Controlled Trial)
This study hypotheses that using low medial cut osteotomy BSSO in mandibular setback can be an efficient and effective method to limit the bony segment interferences , decreasing muscles stripping during osteotomy ,decrease condylar torque and so securing preoperative condylar position during BSSO in comparison with using high medial cut BSSO.
Read the detailed description
Research question:
Description of research question:
P: Population: Patients with facial skeletal deformity and need for mandibular setback using bilateral sagittal split osteotomy (BSSRO) alone or combined with lefort osteotomy.
I: Intervention: Patients with facial skeletal deformity and need and for mandibular setback using low medial cut osteotomy as modification of bilateral sagittal split ramus osteotomy (BSSRO).
C: Comparator: Patients with facial skeletal deformity and need and for mandibular setback using traditional high medial cut osteotomy bilateral sagittal split ramus osteotomy (BSSRO).
O: Outcome: Comparing the post-operative condylar positions changes and TMJ functions of two osteotomies.
Research question:
Is using low medial cut osteotomy modification in BSSRO in mandibular setback will provide more control over proximal segment position than traditional high medial cut through:
- limit the segments interference and so maximizes the passive bony contact across the osteotomy site after surgically repositioning the distal segment
- Passively positioned the proximal segment without displacement of the condyle from its normal position.
- Being tested
- mandibular setback using BSSRO
- Keywords
- mandibular setback, low medial cut, condylar position
- Medical subject headings
- Maxillofacial Abnormalities, 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 using BSSROOther
mandibular setback using BSSRO
| Study group | Role | What they receive |
|---|---|---|
| mandibular setback using low medial cut ostetomy | Experimental | mandibular setback using low medial cut ostetomy by keeping the cut ''low'' or close to the mandibular occlusal plane and ''short'' or terminating anterior to the lingula. Receives: Other: mandibular setback using BSSRO |
| mandibular setback using high medial cut ostetomy | Active comparator | mandibular setback by placement of the medial ramus osteotomy cut 'high', just a few millimeters above the lingula, superior and lateral to the entrance point of the inferior alveolar nerve (IAN) into the mandibular foramen , Receives: Other: mandibular setback using BSSRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D mandibular condylar position changes
assessment of condylar position changes in millimetre using C.T.(axial ,coronal and sagital cut. ).
- Axial condylar head long-axis angle (AHA): angle between the sagittal plane and the axial condylar head axis line
- Axial condylar head position (AHP): perpendicular distance between the sagittal plane and the most medial point of the condylar head
- Frontal condylar head long-axis angle (FHA): angle between the axial plane and the frontal condylar head long-axis line
- Frontal condylar head position (FHP): perpendicular distance between the axial plane and most superior point of the condylar head
- Sagittal condylar head long-axis angle (SHA): angle between the coronal plane and the sagittal condylar head long-axis line
- Sagital condylar head position (SHP): perpendicular distance between the coronal plane and the most superior point of the condylar head
Measured: Preoperative- 1-month postoperative - 6 months post operative
Secondary outcomes (1)
Assessment of changes in articular disc position
In order to trace the position of the TMJ disc, a line was drawn from the uppermost point of the articular fossa (UAF, marked as 10) to the lowermost point of the articular tubercle (LAT, marked as 0).
This line was continued anteriorly and inferiorly. If the anterior border of the disc was anterior to this line, it was considered negative. These two points were chosen because they did not change with remodelling .
Perpendicular lines to this line were drawn in the anterior and posterior borders of the disc. Finally, disc position was determined by averaging anterior (point A) and posterior (point P) disc limits.
Measured: Preoperative , 6month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start28 Sep 2022
- Primary completionApr 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillofacial AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mohammed Mahmoud Hussein Alaswad, Cairo University
- Investigators
- Fahmy Mobarak, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713084
- Sponsor's protocol ID
- 14922
- Status last verified
- Feb 2023
- First submitted
- 21 Jan 2023
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Condylar Position Changes and TMJ Functions After BSSO Mandibular Setback, Low Medial vs High Medial Cut (Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT05713084
- Acronym / sponsor ID
- 14922
- Keywords
- mandibular setback, low medial cut, condylar position
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 6 Feb 2023 (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 hypotheses that using low medial cut osteotomy BSSO in mandibular setback can be an efficient and effective method to limit the bony segment interferences , decreasing muscles stripping during osteotomy ,decrease condylar torque and so securing preoperative condylar position during BSSO in comparison with using high medial cut BSSO.
Detailed description
Research question:
Description of research question:
P: Population: Patients with facial skeletal deformity and need for mandibular setback using bilateral sagittal split osteotomy (BSSRO) alone or combined with lefort osteotomy.
I: Intervention: Patients with facial skeletal deformity and need and for mandibular setback using low medial cut osteotomy as modification of bilateral sagittal split ramus osteotomy (BSSRO).
C: Comparator: Patients with facial skeletal deformity and need and for mandibular setback using traditional high medial cut osteotomy bilateral sagittal split ramus osteotomy (BSSRO).
O: Outcome: Comparing the post-operative condylar positions changes and TMJ functions of two osteotomies.
Research question:
Is using low medial cut osteotomy modification in BSSRO in mandibular setback will provide more control over proximal segment position than traditional high medial cut through:
- limit the segments interference and so maximizes the passive bony contact across the osteotomy site after surgically repositioning the distal segment
- Passively positioned the proximal segment without displacement of the condyle from its normal position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mandibular setback using low medial cut ostetomy | Experimental | Other: mandibular setback using BSSROmandibular setback using low medial cut ostetomy by keeping the cut ''low'' or close to the mandibular occlusal plane and ''short'' or terminating anterior to the lingula. |
| mandibular setback using high medial cut ostetomy | Active comparator | Other: mandibular setback using BSSROmandibular setback by placement of the medial ramus osteotomy cut 'high', just a few millimeters above the lingula, superior and lateral to the entrance point of the inferior alveolar nerve (IAN) into the mandibular foramen , |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age of the patient between (18-60) years
- Patients in need of mandibular setback using bilateral sagittal split osteotomy.
- All patients are free from any systemic disease that may affect normal bone healing.
- Patient with facial deformity will be treated with mandibular setback either mono or bimaxilary surgeries
- Patient with facial deformity will be treated with mandibular setback either surgery first approach or orthofirst approach.
Key exclusion criteria (4 listed)
- Patients with any systemic disease that may affect normal healing
- Intra-bony lesions or infections that may interfere with surgery.
- Previous orthognathic surgeries.
- Patients with all types of facial clefts
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 using BSSROmandibular setback using BSSRO | Other | mandibular setback using high medial cut ostetomy, mandibular setback using low medial cut ostetomy |
Primary outcome
3D mandibular condylar position changes
Time frame: Preoperative- 1-month postoperative - 6 months post operative
assessment of condylar position changes in millimetre using C.T.(axial ,coronal and sagital cut. ). 1. Axial condylar head long-axis angle (AHA): angle between the sagittal plane and the axial condylar head axis line 2. Axial condylar head position (AHP): perpendicular distance between the sagittal plane and the most medial point of the condylar head 3. Frontal condylar head long-axis angle (FHA): angle between the axial plane and the frontal condylar head long-axis line 4. Frontal condylar head position (FHP): perpendicular distance between the axial plane and most superior point of the condylar head 5. Sagittal condylar head long-axis angle (SHA): angle between the coronal plane and the sagittal condylar head long-axis line 6. Sagital condylar head position (SHP): perpendicular distance between the coronal plane and the most superior point of the condylar head
1 secondary outcome
Assessment of changes in articular disc position
Time frame: Preoperative , 6month postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
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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.
Fahmy Mobarak, professor 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 using BSSRO in people with Maxillofacial Abnormalities and Mandible Prognathism, run by Cairo 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 7 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: status not confirmed, as of the sponsor's last update on 6 Feb 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?
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?
3D mandibular condylar position changes (time frame: Preoperative- 1-month postoperative - 6 months post operative). 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 6 Feb 2023.