Patient-Specific vs. Conventional Positioning in Sagittal Split Ramus Osteotomy

NCT07125963 | Recruiting

• 1 other identifier: MEDIPOL-SSRO-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the clinical efficacy and positioning accuracy of a custom-made proximal segment positioning appliance designed for use in sagittal split ramus osteotomy (SSRO). The appliance is produced using STL-based digital planning and 3D printing technologies. In each patient, the appliance is applied to one side of the mandible while the contralateral side is positioned using the conventional manual method. This within-subject design enables direct comparison by eliminating inter-individual anatomical variability. The primary outcome is the accuracy of segment positioning, evaluated by 3D superimposition and deviation analysis of pre- and postoperative STL models. Secondary outcomes include surgical time, ease of use as rated by the surgeon, and postoperative temporomandibular joint symptoms. The study will enroll 30 adult patients undergoing SSRO or double-jaw surgery due to dentofacial deformities. The results are expected to provide high-level clinical evidence for the reliability of patient-specific appliances in orthognathic surgery.

Conditions

Dentofacial Deformities

Keywords

Sagittal Split Ramus Osteotomy; Orthognathic Surgery; 3D Surgical Planning; Patient-Specific Guide; Proximal Segment Position

Outcome Measures

Primary Outcomes (1)

• Deviation of the proximal mandibular segment from the preoperative plan

  The deviation between the actual postoperative position of the proximal mandibular segment and the virtually planned position will be measured in millimeters using superimposed STL files in MeshLab software. The mean deviation value will be compared between the custom-made positioning appliance-assisted method and conventional manual positioning to assess positional accuracy.

  1 Month Postoperatively

Secondary Outcomes (1)

• Duration of Fixation After Split

  Intraoperative

Study Arms (2)

Custom-made positioning appliance-assisted mandibular segment repositioning

EXPERIMENTAL

Patients receive a custom-made positioning appliance designed via STL-based planning and manufactured using 3D printing. The appliance is used to guide the proximal mandibular segment during sagittal split ramus osteotomy on one side of the mandible, aiming to improve positional accuracy.

Procedure: Custom-made positioning appliance-assisted mandibular segment repositioning

Conventional Manual Positioning

ACTIVE COMPARATOR

On the contralateral side of the mandible, the proximal segment is positioned manually by the surgeon using standard visual and tactile feedback during sagittal split ramus osteotomy, without a guiding appliance.

Procedure: Conventional Manual Positioning

Interventions

Custom-made positioning appliance-assisted mandibular segment repositioning PROCEDURE

A patient-specific surgical guide designed using STL-based digital planning in Blender and produced via 3D printing with biocompatible surgical resin (Formlabs SLA printer). Used to guide and stabilize the proximal mandibular segment during sagittal split ramus osteotomy.

Custom-made positioning appliance-assisted mandibular segment repositioning

Conventional Manual Positioning PROCEDURE

The proximal mandibular segment is positioned manually by the surgeon based on visual and tactile feedback without the use of a positioning guide. This technique represents the standard method in sagittal split ramus osteotomy.

Conventional Manual Positioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo bilateral sagittal split ramus osteotomy as part of orthognathic surgery
• Age ≥ 18 years
• Availability of preoperative and postoperative CT scans
• Consent to participate in the study

You may not qualify if:

• History of previous mandibular surgery
• Craniofacial syndromes or congenital deformities
• Incomplete radiological records

Sponsors & Collaborators

• Sümer Münevveroğlu: lead

Study Sites (1)

Istanbul Medipol University, Medipol Mega University Hospital

Istanbul, Bağcılar, 34218, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Dentofacial Deformities

Condition Hierarchy (Ancestors)

Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Sümer Münevveroğlu, D.D.S., Ph.D.

CONTACT

00905386013666; sumer.munevveroglu@medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study uses a split-mouth crossover design. Each patient receives both interventions: a custom-made positioning appliance is applied to one side of the mandible, while the contralateral side is positioned using the conventional manual method. This intra-patient comparison allows direct assessment of positional accuracy and clinical effectiveness between the two techniques.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 15, 2025
• Study Start: January 25, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)