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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-25

Study Completion Date

2026-10-30

Brief Summary

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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.

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Detailed Description

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Sagittal split ramus osteotomy (SSRO) is a widely used orthognathic surgery technique to correct mandibular deformities. During SSRO, accurate positioning of the proximal segment is critical for ensuring temporomandibular joint (TMJ) health, symmetry, and long-term surgical stability. However, conventional positioning relies heavily on the surgeon's visual judgment and experience, which may lead to postoperative complications such as condylar displacement, facial asymmetry, and TMJ dysfunction.

This prospective, randomized clinical study introduces a patient-specific proximal segment positioning appliance developed through STL-based 3D design using Blender and printed with biocompatible surgical guide resin via a Formlabs SLA 3D printer. Each patient will undergo SSRO (with or without Le Fort I osteotomy), and the custom appliance will be used to guide the proximal segment on one mandibular side. The opposite side will be positioned conventionally, allowing intra-patient comparison.

Postoperative CBCT images will be obtained at 1 month and converted to STL format. These models will be aligned with preoperative plans using MeshLab software to evaluate linear and rotational deviations. Surgical time, ease of application, and TMJ symptoms will be documented. Statistical analysis will include paired t-tests or Wilcoxon signed-rank tests depending on data distribution.

This study will generate clinically meaningful data regarding the effectiveness and safety of patient-specific guides in mandibular segment positioning. The proposed method also holds commercialization potential and may reduce intraoperative variability and dependence on surgeon experience.

Conditions

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Dentofacial Deformities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Custom-made positioning appliance-assisted mandibular segment repositioning

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.

Group Type EXPERIMENTAL

Custom-made positioning appliance-assisted mandibular segment repositioning

Intervention Type 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.

Conventional Manual Positioning

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.

Group Type ACTIVE_COMPARATOR

Conventional Manual Positioning

Intervention Type 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.

Interventions

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Custom-made positioning appliance-assisted mandibular segment repositioning

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.

Intervention Type PROCEDURE

Conventional Manual Positioning

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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