Class III MalocclusionNCT05397002
Patient Specific Intraoral Inverted-L Osteotomy Modified With Inferior Alveolar Nerve Relocation in Corrective Mandibular Surgery
A study testing patient specific inverted L mandibular osteotomy modified with inferior alveolar nerve relocation in people with Class III Malocclusion, run by Cairo University at 1 site in Egypt.
Trial summary
Bilateral sagittal split osteotomy (BSSO) is considered the main osteotomy design in corrective mandibular surgery, however abnormal anatomical configuration of the posterior mandible with rolled out inferior border and thin mandibular rami with cortically adherent inferior alveolar nerve may interfere with the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Class III Malocclusion
- What is being tested?
- patient specific inverted L mandibular osteotomy modified with inferior alveolar nerve relocation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 10 Apr 2022
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients.
- patients with skeletal class III malocclusion.
- Patients with thin mandibular rami with minimal medullary bone.
- Patients with inferior alveolar nerve proximity to the buccal cortex.
- Patients with lateral bending of the inferior mandibular border at molar angle region.
- Patients with high mandibular foramen.
Who cannot join
- Patients with previous extensive jaw surgery.
- mandibular pathological lesions.
- Patients with temporomandibular joint dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
Bilateral sagittal split osteotomy (BSSO) is considered the main osteotomy design in corrective mandibular surgery, however abnormal anatomical configuration of the posterior mandible with rolled out inferior border and thin mandibular rami with cortically adherent inferior alveolar nerve may interfere with the utilization of this osteotomy. The aim of this study is to introduce a novel modification of the intraoral inverted L ramus osteotomy (ILRO) to overcome these limitations in mandibular setback surgery. preoperative CBCT was requested for virtual planning and fabrication of cutting and drilling guides. Cutting lines were outlined to be consisted of four cuts; lateral ostectomy to uncover and lateralize the inferior alveolar nerve (IAN), posterior cut run horizontally from the anterior border of the ramus to a point just above the mandibular foramen, two anterior vertical cuts run from the anterior end of the lateral ostectomy to the inferior mandibular border. The guide was removed and the osteotomy lines were completed then the mandibular setback was oriented and fixed using pre-bent plates osteosynthesis. Inferior alveolar nerve function was regained perfectly one year post-operatively. This procedure introduces a robust alternative to the BSSO osteotomy in some cases of mandibular setback surgery.
- Conditions
- Class III Malocclusion
- Being tested
- patient specific inverted L mandibular osteotomy modified with inferior alveolar nerve relocation
- 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.
patient specific inverted L mandibular osteotomy modified with inferior alveolar nerve relocationProcedure or surgery
preoperative CBCT was requested for virtual planning and fabrication of cutting and drilling guides. Cutting lines were outlined to be consisted of four cuts; lateral ostectomy to uncover and lateralize the inferior alveolar nerve (IAN), posterior cut run horizontally from the anterior border of the ramus to a point just above the mandibular foramen, two anterior vertical cuts run from the anterior end of the lateral ostectomy to the inferior mandibular border. The guide was removed and the osteotomy lines were completed then the mandibular setback was oriented and fixed using pre-bent plates osteosynthesis. Plane transfer was checked using CBCT and Inferior alveolar nerve function was assessed.
| Study group | Role | What they receive |
|---|---|---|
| Patient with class III malocclusion | Other | Not described Receives: Procedure: patient specific inverted L mandibular osteotomy modified with inferior alveolar nerve relocation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurosensory dysfunction of Inferior Alveolar Nerve
Neurosensory test: two-point discrimination test
Measured: one year after surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Oct 2020
- Primary completion10 Apr 2022
- Study completion10 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class III MalocclusionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abdel Salam Ibrahim Omara, Cairo University
- Investigators
- Mohammed Omara, Lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397002
- Sponsor's protocol ID
- OMFS -1-10-20
- Status last verified
- May 2022
- First submitted
- 23 May 2022
- Last updated
- 31 May 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 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Specific Intraoral Inverted-L Osteotomy Modified With Inferior Alveolar Nerve Relocation in Corrective Mandibular Surgery
- ClinicalTrials.gov ID
- NCT05397002
- Acronym / sponsor ID
- OMFS -1-10-20
- Conditions
- Class III Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 10 Apr 2022 (actual)
- Study completion
- 10 Apr 2022 (actual)
- First posted
- 31 May 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.
Bilateral sagittal split osteotomy (BSSO) is considered the main osteotomy design in corrective mandibular surgery, however abnormal anatomical configuration of the posterior mandible with rolled out inferior border and thin mandibular rami with cortically adherent inferior alveolar nerve may interfere with the utilization of this osteotomy. The aim of this study is to introduce a novel modification of the intraoral inverted L ramus osteotomy (ILRO) to overcome these limitations in mandibular setback surgery. preoperative CBCT was requested for virtual planning and fabrication of cutting and drilling guides. Cutting lines were outlined to be consisted of four cuts; lateral ostectomy to uncover and lateralize the inferior alveolar nerve (IAN), posterior cut run horizontally from the anterior border of the ramus to a point just above the mandibular foramen, two anterior vertical cuts run from the anterior end of the lateral ostectomy to the inferior mandibular border. The guide was removed and the osteotomy lines were completed then the mandibular setback was oriented and fixed using pre-bent plates osteosynthesis. Inferior alveolar nerve function was regained perfectly one year post-operatively. This procedure introduces a robust alternative to the BSSO osteotomy in some cases of mandibular setback surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with class III malocclusion | Other | Procedure: patient specific inverted L mandibular osteotomy modified with inferior alveolar nerve relocation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients.
- patients with skeletal class III malocclusion.
- Patients with thin mandibular rami with minimal medullary bone.
- Patients with inferior alveolar nerve proximity to the buccal cortex.
- Patients with lateral bending of the inferior mandibular border at molar angle region.
Key exclusion criteria (3 listed)
- Patients with previous extensive jaw surgery.
- mandibular pathological lesions.
- Patients with temporomandibular joint dysfunction.
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 |
|---|---|---|
| patient specific inverted L mandibular osteotomy modified with inferior alveolar nerve relocationpreoperative CBCT was requested for virtual planning and fabrication of cutting and drilling guides. Cutting lines were outlined to be consisted of four cuts; lateral ostectomy to uncover and lateralize the inferior alveolar nerve (IAN), posterior cut run horizontally from the anterior border of the ramus to a point just above the mandibular foramen, two anterior vertical cuts run from the anterior end of the lateral ostectomy to the inferior mandibular border. The guide was removed and the osteotomy lines were completed then the mandibular setback was oriented and fixed using pre-bent plates osteosynthesis. Plane transfer was checked using CBCT and Inferior alveolar nerve function was assessed. | Procedure or surgery | Patient with class III malocclusion |
Primary outcome
Neurosensory dysfunction of Inferior Alveolar Nerve
Time frame: one year after surgical intervention
Neurosensory test: two-point discrimination test
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 31 May 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.
Mohammed Omara, Lecturer principal investigator
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 patient specific inverted L mandibular osteotomy modified with inferior alveolar nerve relocation in people with Class III Malocclusion, 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 6 inclusion and 3 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 31 May 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?
Neurosensory dysfunction of Inferior Alveolar Nerve (time frame: one year after surgical intervention). 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 31 May 2022.