Skeletal Class II MalocclusionNCT07746700
Clinical and Radiographic Evaluation of Low Sagittal Medial Ramus Osteotomy for Treatment of Skeletal Class II and Class III Malocclusion
A study testing Low Sagittal Medial Ramus Osteotomy in people with Skeletal Class II Malocclusion and Skeletal Class III Malocclusion, run by Al-Azhar University.
Trial summary
This prospective clinical trial aims to evaluate the clinical and radiographic outcomes of the low sagittal medial ramus osteotomy-a technical modification of the conventional sagittal split osteotomy (SSO)-for treating patients with skeletal Class II and Class III malocclusions. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Skeletal Class II Malocclusion, Skeletal Class III Malocclusion, Dentofacial Deformities
- What is being tested?
- Low Sagittal Medial Ramus Osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with skeletal Class II or Class III malocclusion requiring mandibular orthognathic surgery.
- Age range from 18 to 45 years old.
- Systematically healthy patients classified as ASA physical status I or II (American Society of Anesthesiologists)
Who cannot join
- Patients with a pre-existing history of inferior alveolar nerve (IAN) sensory impairment.
- Patients with active or severe degenerative joint disease (DJD).
- Patients with a prior history of orthognathic surgical procedures.
- Patients presenting with systemic diseases or conditions known to compromise normal bone healing.
About this study
This prospective clinical trial aims to evaluate the clinical and radiographic outcomes of the low sagittal medial ramus osteotomy-a technical modification of the conventional sagittal split osteotomy (SSO)-for treating patients with skeletal Class II and Class III malocclusions.
Standard sagittal split osteotomies carry risks of complications, including unfavorable osteotomy propagation (bad splits) toward the condyle, ramus fragmentation, lingual interference of the distal segment, and inferior alveolar nerve (IAN) injury. To minimize these risks, this study utilizes a modified medial cut positioned low (below the lingula in an area with adequate marrow space) and short (terminating anterior to the lingula). This design aims to prevent osteotomy extension into the condylar region and eliminate lingual interference during segment repositioning.
- Being tested
- Low Sagittal Medial Ramus Osteotomy
- Keywords
- Orthognathic Surgery, Sagittal Split Osteotomy, Skeletal Class II Malocclusion, Skeletal Class III Malocclusion
- Medical subject headings
- Dentofacial Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Sagittal Medial Ramus OsteotomyProcedure or surgery
Patients undergoing orthognathic surgery using the low sagittal medial ramus osteotomy modification. The medial osteotomy cut is initiated slightly above the mandibular occlusal plane, positioned low (below the lingula in an area with adequate marrow space) and short (terminating anterior to the lingula and retrolingual fossa) to achieve 3D mandibular repositioning guided by CAD/CAM virtual surgical planning.
| Study group | Role | What they receive |
|---|---|---|
| Low Sagittal Medial Ramus Osteotomy Group | Experimental | Patients undergoing orthognathic surgery using the low sagittal medial ramus osteotomy modification. The medial osteotomy cut is initiated slightly above the mandibular occlusal plane, positioned low (below the lingula in an area with adequate marrow space) and short (terminating anterior to the lingula and retrolingual fossa) to achieve 3D mandibular repositioning guided by CAD/CAM virtual surgical planning. Receives: Procedure: Low Sagittal Medial Ramus Osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Unfavorable Osteotomy Split ("Bad Split")
Intraoperative evaluation of the occurrence of unfavorable osteotomy propagation (e.g., condylar neck fracture, ramus fragmentation, or buccal/lingual plate fracture) during the sagittal split procedure, assessed via direct visualization and manual palpation.
Measured: Intraoperative (during the surgical procedure)
Secondary outcomes (10)
Change from Baseline in Inferior Alveolar Nerve (IAN) Conduction Latency via TSSEP
Objective electrophysiological assessment of IAN neurosensory function measured using Trigeminal Somatosensory Evoked Potentials (TSSEP). Unit of Measure: Milliseconds (ms)
Measured: Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively
Number of Participants with IAN Entrapment in the Proximal Segment
Direct intraoperative visual assessment to report the frequency of the inferior alveolar nerve being contained within the proximal segment versus the distal segment immediately following sagittal splitting
Measured: Intraoperative (during the surgical procedure)
Incidence of Distal Segment Lingual Bony Interference
intraoperative assessment of lingual bony interference during distal segment positioning into the planned occlusal alignment. Evaluated as a categorical outcome: Presence (bony contact requiring additional osteotomy modification or recontouring to achieve passive seating) vs. Absence (passive seating achieved without bony contact). Unit of Measure: Number of participants
Measured: Intraoperative (during the surgical procedure)
Condylar Position within the Glenoid Fossa via Panoramic Radiography
Postoperative radiographic assessment using panoramic radiographs to confirm anatomical centering and placement of the condyle within the glenoid fossa. Evaluated as Adequate Position vs. Displaced Position
Measured: Postoperative Day 7 (within the first week postoperatively)
Skeletal Stability and Surgical Movement Outcome
Cephalometric analysis comparing preoperative and postoperative lateral cephalograms to evaluate the gained orthognathic movement and skeletal treatment outcome.
Measured: 3 months postoperatively
Change from Baseline in SNB Angle via Lateral Cephalometry
Radiographic assessment of horizontal mandibular repositioning and skeletal outcome by measuring the change in the SNB angle on lateral cephalometric radiographs. Unit of Measure: Degrees
Measured: Baseline (preoperative) and 3 months postoperatively
Change from Baseline in Inferior Alveolar Nerve (IAN) Peak Amplitude via TSSEP
Objective electrophysiological assessment of IAN signal amplitude measured using Trigeminal Somatosensory Evoked Potentials (TSSEP). Unit of Measure: Microvolts
Measured: Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively
Change from Baseline in Linear Pogonion Advancement (Pog-NB Distance) via Lateral Cephalometry
Radiographic assessment of skeletal advancement and stability measured as the linear distance from Pogonion (Pog) to the NB perpendicular line on lateral cephalometric radiographs. Unit of Measure: Millimeters ($\text{mm}$)
Measured: Baseline (preoperative) and 3 months postoperatively.
Frequency of Complete Bony Bridging at the Osteotomy Site via 3D CT Scan
Radiographic assessment of bone healing across the low sagittal medial ramus osteotomy site evaluated on 3D facial Computed Tomography (CT) scans. Categorized as Complete Healing (continuous cortical/cancellous bone bridging across the osteotomy line) vs. Incomplete Healing (persistent radiolucent gap or non-union). Unit of Measure: Number of participants
Measured: 6 months postoperatively.
Presence of Condylar Bony Alterations via 3D CT Scan
Radiographic evaluation of temporomandibular joint (TMJ) condylar head integrity assessed on 3D facial CT scans. Categorized as Normal (intact condylar surface) vs. Altered (presence of bony remodeling, erosion, or resorption). Unit of Measure: Number of participants
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Class II MalocclusionStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, omar abdelhamid elbana, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746700
- Sponsor's protocol ID
- 1345/3938
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Low Sagittal Medial Ramus Osteotomy for Treatment of Skeletal Class II and Class III Malocclusion
- ClinicalTrials.gov ID
- NCT07746700
- Acronym / sponsor ID
- 1345/3938
- Keywords
- Orthognathic Surgery, Sagittal Split Osteotomy, Skeletal Class II Malocclusion, Skeletal Class III Malocclusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 5 Aug 2026 (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 prospective clinical trial aims to evaluate the clinical and radiographic outcomes of the low sagittal medial ramus osteotomy-a technical modification of the conventional sagittal split osteotomy (SSO)-for treating patients with skeletal Class II and Class III malocclusions.
Standard sagittal split osteotomies carry risks of complications, including unfavorable osteotomy propagation (bad splits) toward the condyle, ramus fragmentation, lingual interference of the distal segment, and inferior alveolar nerve (IAN) injury. To minimize these risks, this study utilizes a modified medial cut positioned low (below the lingula in an area with adequate marrow space) and short (terminating anterior to the lingula). This design aims to prevent osteotomy extension into the condylar region and eliminate lingual interference during segment repositioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Sagittal Medial Ramus Osteotomy Group | Experimental | Procedure: Low Sagittal Medial Ramus OsteotomyPatients undergoing orthognathic surgery using the low sagittal medial ramus osteotomy modification. The medial osteotomy cut is initiated slightly above the mandibular occlusal plane, positioned low (below the lingula in an area with adequate marrow space) and short (terminating anterior to the lingula and retrolingual fossa) to achieve 3D mandibular repositioning guided by CAD/CAM virtual surgical planning. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with skeletal Class II or Class III malocclusion requiring mandibular orthognathic surgery.
- Age range from 18 to 45 years old.
- Systematically healthy patients classified as ASA physical status I or II (American Society of Anesthesiologists)
Key exclusion criteria (4 listed)
- Patients with a pre-existing history of inferior alveolar nerve (IAN) sensory impairment.
- Patients with active or severe degenerative joint disease (DJD).
- Patients with a prior history of orthognathic surgical procedures.
- Patients presenting with systemic diseases or conditions known to compromise normal bone healing.
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 |
|---|---|---|
| Low Sagittal Medial Ramus OsteotomyPatients undergoing orthognathic surgery using the low sagittal medial ramus osteotomy modification. The medial osteotomy cut is initiated slightly above the mandibular occlusal plane, positioned low (below the lingula in an area with adequate marrow space) and short (terminating anterior to the lingula and retrolingual fossa) to achieve 3D mandibular repositioning guided by CAD/CAM virtual surgical planning. | Procedure or surgery | Low Sagittal Medial Ramus Osteotomy Group |
Primary outcome
Number of Participants with Unfavorable Osteotomy Split ("Bad Split")
Time frame: Intraoperative (during the surgical procedure)
Intraoperative evaluation of the occurrence of unfavorable osteotomy propagation (e.g., condylar neck fracture, ramus fragmentation, or buccal/lingual plate fracture) during the sagittal split procedure, assessed via direct visualization and manual palpation.
10 secondary outcomes
Change from Baseline in Inferior Alveolar Nerve (IAN) Conduction Latency via TSSEP
Time frame: Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively
Number of Participants with IAN Entrapment in the Proximal Segment
Time frame: Intraoperative (during the surgical procedure)
Incidence of Distal Segment Lingual Bony Interference
Time frame: Intraoperative (during the surgical procedure)
Condylar Position within the Glenoid Fossa via Panoramic Radiography
Time frame: Postoperative Day 7 (within the first week postoperatively)
Skeletal Stability and Surgical Movement Outcome
Time frame: 3 months postoperatively
Change from Baseline in SNB Angle via Lateral Cephalometry
Time frame: Baseline (preoperative) and 3 months postoperatively
Change from Baseline in Inferior Alveolar Nerve (IAN) Peak Amplitude via TSSEP
Time frame: Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively
Change from Baseline in Linear Pogonion Advancement (Pog-NB Distance) via Lateral Cephalometry
Time frame: Baseline (preoperative) and 3 months postoperatively.
Frequency of Complete Bony Bridging at the Osteotomy Site via 3D CT Scan
Time frame: 6 months postoperatively.
Presence of Condylar Bony Alterations via 3D CT Scan
Time frame: 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Low Sagittal Medial Ramus Osteotomy in people with Skeletal Class II Malocclusion and Skeletal Class III Malocclusion, run by Al-Azhar University.
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 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: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Number of Participants with Unfavorable Osteotomy Split ("Bad Split") (time frame: Intraoperative (during the surgical procedure)). 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 5 Aug 2026.