Skeletal AbnormalitiesNCT03983265
Condylar Segment Repositioning Using CAD/CAM Generated Wafer After BSSO in Skeletal Mandibular Deformity
A study testing Bilateral Sagittal Split Osteotomy in people with Skeletal Abnormalities, run by Cairo University at 1 site in Egypt.
Trial summary
Maintaining the condylar position after bilateral sagittal split ramus osteotomy (BSSO) is one of the most important aspects in terms of condylar function ,.An altered condylar position can cause internal derangement of the joint, loss of the mandibular angle, increased risk of relapse, condyle sagging, and impaired… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Skeletal Abnormalities
- What is being tested?
- Bilateral Sagittal Split Osteotomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2018to Jan 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age of the patient above 18 years
- Patients needs bilateral sagittal split osteotomy
- All patients are free from any systemic disease that may affect normal bone healing
- Sufficient dentition to reproduce the occlusal relationships
- Patient's consent to participate
Who cannot join
- Patient with TMJ Disorders
- Patients with any systemic disease that may affect normal healing
- Intra-bony lesions or infections that may interfere with surgery.the presence of
- Previous orthognathic surgeries
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
oral and dental medicine Cairo university
Giza, 12613
yara mamdouh, BDS, 01002955632, yara.mustafa@dentistry.cu.edu.eg
Mohammed omara, PHD, 01144452862, omara_mohammed@ymail.com
About this study
Official title: Condylar/Proximal Segments Repositioning Using CAD/CAM Generated Wafer After Bilateral Sagittal Split Osteotomy in Skeletal Mandibular Deformity
Maintaining the condylar position after bilateral sagittal split ramus osteotomy (BSSO) is one of the most important aspects in terms of condylar function ,.An altered condylar position can cause internal derangement of the joint, loss of the mandibular angle, increased risk of relapse, condyle sagging, and impaired masticatory function.
In previous years, a great deal of attention has been paid to maintaining the preoperative condylar position during orthognathic surgery. Numerous condylar positioning methods have been reported and could be divided into manual/empirical methods, conventional methods , navigation, and sonographic monitoring, Computer guided methods which is more accurate than other methods
Read the detailed description
unpredictable condylar position after orthognathic surgery, will lead to malocclusion, derangement of the condylar surface, condylar resorption, condylar sag, distraction of the condyles from the fosse. In previous years, several authors had been adopted several techniques to maintain the preoperative condylar position during orthognathic surgery. Numerous condylar positioning methods have been reported which could be divided into conventional techniques (manual maneuvers or aiding tools), Extra and intra oral navigational techniques , surgeons had been utilized these techniques in condylar repositiong after BSSO but it was time and effort consuming and sometimes it was inaccurate. the aim for conducting the research is accurate positioning of condyle three dimensionally to minimize effort and operating time of surgery .
- Conditions
- Skeletal Abnormalities
- Being tested
- Bilateral Sagittal Split Osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Sagittal Split OsteotomyOther
after BSSO condyle will be re positioned by using computer guided device
| Study group | Role | What they receive |
|---|---|---|
| computer guided condylar reposition device | Other | surgical procedure : under general anesthesia after BSSO condyle will be repositioned by computer guided repostioning device Receives: Other: Bilateral Sagittal Split Osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of postoperative condylar position in relation to the corrected virtual model
the accuracy of postoperative condylar position will be assessed using Mimics soft ware ,measuring unit (mm)
Measured: immediate postoperative
Secondary outcomes (1)
operative time
surgical time will be assessed via clinical assessment measuring unit (hours)
Measured: during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start20 Nov 2018
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Condylar/Proximal Segments Repositioning Using CAD/CAM Generated Wafer After Bilateral Sagittal Split Osteotomy in Skeletal Mandibular Deformity
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yara mamdouh mustafa, Cairo University
- Investigators
- Mohammed omara, Lecturer, Study director, faculty of oral and dental medicine Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983265
- Sponsor's protocol ID
- ymmustafa
- Status last verified
- Jun 2019
- First submitted
- 7 Jun 2019
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Condylar/Proximal Segments Repositioning Using CAD/CAM Generated Wafer After Bilateral Sagittal Split Osteotomy in Skeletal Mandibular Deformity
- ClinicalTrials.gov ID
- NCT03983265
- Acronym / sponsor ID
- ymmustafa
- Conditions
- Skeletal Abnormalities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 12 Jun 2019 (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.
Maintaining the condylar position after bilateral sagittal split ramus osteotomy (BSSO) is one of the most important aspects in terms of condylar function ,.An altered condylar position can cause internal derangement of the joint, loss of the mandibular angle, increased risk of relapse, condyle sagging, and impaired masticatory function.
In previous years, a great deal of attention has been paid to maintaining the preoperative condylar position during orthognathic surgery. Numerous condylar positioning methods have been reported and could be divided into manual/empirical methods, conventional methods , navigation, and sonographic monitoring, Computer guided methods which is more accurate than other methods
Detailed description
unpredictable condylar position after orthognathic surgery, will lead to malocclusion, derangement of the condylar surface, condylar resorption, condylar sag, distraction of the condyles from the fosse. In previous years, several authors had been adopted several techniques to maintain the preoperative condylar position during orthognathic surgery. Numerous condylar positioning methods have been reported which could be divided into conventional techniques (manual maneuvers or aiding tools), Extra and intra oral navigational techniques , surgeons had been utilized these techniques in condylar repositiong after BSSO but it was time and effort consuming and sometimes it was inaccurate. the aim for conducting the research is accurate positioning of condyle three dimensionally to minimize effort and operating time of surgery .
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Condylar/Proximal Segments Repositioning Using CAD/CAM Generated Wafer After Bilateral Sagittal Split Osteotomy in Skeletal Mandibular Deformity
| Arm | Type | Receives |
|---|---|---|
| computer guided condylar reposition device | Other | Other: Bilateral Sagittal Split Osteotomysurgical procedure : under general anesthesia after BSSO condyle will be repositioned by computer guided repostioning device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age of the patient above 18 years
- Patients needs bilateral sagittal split osteotomy
- All patients are free from any systemic disease that may affect normal bone healing
- Sufficient dentition to reproduce the occlusal relationships
- Patient's consent to participate
Key exclusion criteria (4 listed)
- Patient with TMJ Disorders
- Patients with any systemic disease that may affect normal healing
- Intra-bony lesions or infections that may interfere with surgery.the presence of
- Previous orthognathic surgeries
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 |
|---|---|---|
| Bilateral Sagittal Split Osteotomyafter BSSO condyle will be re positioned by using computer guided device | Other | computer guided condylar reposition device |
Primary outcome
accuracy of postoperative condylar position in relation to the corrected virtual model
Time frame: immediate postoperative
the accuracy of postoperative condylar position will be assessed using Mimics soft ware ,measuring unit (mm)
1 secondary outcome
operative time
Time frame: during operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Computer-assisted orthognathic surgery: feasibility study using multiple CAD/CAM surgical splintsLink provided by the sponsor.
- Orthognathic Positioning System: Intraoperative System to Transfer Virtual Surgical Plan to Operating Field During Orthognathic SurgeryLink provided by the sponsor.
- Clinical and radiographic evaluation of a computer-generated guiding device in bilateral sagittal split osteotomiesLink provided by the sponsor.
- A novel method for the management of proximal segment using computer assisted simulation surgery: correct condyle head positioning and better proximal segment placementLink provided by the sponsor.
- 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.
Mohammed omara, Lecturer study director
faculty of oral and dental medicine 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 Bilateral Sagittal Split Osteotomy in people with Skeletal Abnormalities, 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 5 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 12 Jun 2019. 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?
Contact yara mamdouh mustafa, BDS (01002955632, yara.mustafa@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of postoperative condylar position in relation to the corrected virtual model (time frame: immediate postoperative). 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 12 Jun 2019.