Menu
Not yet recruiting NCT07746700

Clinical and Radiographic Evaluation of Low Sagittal Medial Ramus Osteotomy for Treatment of Skeletal Class II and Class III Malocclusion

No phase Interventional Skeletal Class II Malocclusion Skeletal Class III Malocclusion Dentofacial Deformities

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low Sagittal Medial Ramus Osteotomy.
Who it may be relevant to
Registry conditions: Skeletal Class II Malocclusion, Skeletal Class III Malocclusion, Dentofacial Deformities. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure Low Sagittal Medial Ramus Osteotomy
    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.

Primary outcome measures

  • Number of Participants with Unfavorable Osteotomy Split ("Bad Split") [Time frame: Intraoperative (during the surgical procedure)]
Secondary outcome measures (10)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07746700 · 1345/3938

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗