Analysis of Mandibular Proximal Segment Position Using Virtual Orthognathic Surgical Planning, Individualized Guides, and Osteosynthesis Plates

NCT06442787 | Recruiting

• 1 other identifier: E-54022451-050.04-150505
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Orthognathic surgery is a surgical procedure performed to correct dentofacial deformities. In recent years, with the use of virtual surgical planning, cutting guides, and patient-specific osteosynthesis plates, highly predictable results can be achieved. While there are many positive reports regarding the use of patient-specific plates in maxillary positioning in orthognathic surgery, there is a lack of sufficient studies comparing the results obtained in mandibular positioning. Additionally, numerous designs of proximal segment positioning devices have been published, but comparative studies on their effectiveness have not been conducted. Therefore, a study comparing these approaches has been planned.

Conditions

CAD-CAM; Patients Specific Manufacturing; Osteotomy, Sagittal Split Ramus

Keywords

virtual surgical planning; orthognathic surgery; custom plate; mandibular condyle position

Outcome Measures

Primary Outcomes (1)

• mandibular condyle changes

  Firstly; The following reference planes and lines will be created on the Mimics (Materialise, Belgium, v21) software: * Frankfort Horizontal Plane (FHD): Right and left side porion and the plane passing through the right side orbitale * Midsagittal Reference Plane (MSR): Perpendicular to FHD, nasion and plane determined to pass through basion points Lateral Condylar Pole (LKK) (Right-Left): the outermost part of the condyle head point * Medial Condylar Pole (MKK) (Right-Left): innermost part of the condyle head point Linear and angular measurements to be made with these planes.

  in the first week after the surgery

Secondary Outcomes (1)

• Rate of the virtual surgical planning accuracy

  in the first week after the surgery

Study Arms (3)

control group

EXPERIMENTAL

Orthognathic surgery will be performed (n=20) (control group)

Device: conventional splints

group 2

ACTIVE COMPARATOR

Orthognathic surgery will be performed (n=20)

Device: cutting guides and positioning guides

group 3

ACTIVE COMPARATOR

Orthognathic surgery will be performed (n=20)

Device: cutting guides and fixation plates

Interventions

conventional splints DEVICE

only intermediate and final splint will be used during the surgery

control group

cutting guides and positioning guides DEVICE

patient's specific manufacturing cutting guide and positioning guide related with orthognathic surgery

group 2

cutting guides and fixation plates DEVICE

patient's specific manufacturing cutting guide and fixation plates related with orthognathic surgery

group 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals over 18 years of age
• Patients with skeletal Class 2 and Class 3 malocclusion requiring bimaxillary orthognathic surgery
• Patients who have undergone orthodontic treatment prior to surgery

You may not qualify if:

• Patients with cleft lip and palate or craniofacial deformities
• Oligodontia
• Patients in whom the study protocol could not be continued due to intraoperative complications such as guide mismatch or bad split, or due to reasons such as inability to obtain postoperative CT scans
• Patients with pre-existing temporomandibular joint disorders prior to surgery
• Patients who have undergone previous orthognathic surgery
• Patients with a history of maxillary or mandibular trauma
• Patients requiring segmental maxillary surgery
• Patients with bone metabolism disorders
• Patients allergic to titanium
• Pregnant individuals

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf Universty

Istanbul, Fatih, 34093, Turkey (Türkiye)

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Orthognathic surgery is a surgical procedure performed to correct dentofacial deformities. In recent years, with the use of virtual surgical planning, cutting guides, and patient-specific osteosynthesis plates, highly predictable results can be achieved. While there are many positive reports regarding the use of patient-specific plates in maxillary positioning in orthognathic surgery, there is a lack of sufficient studies comparing the results obtained in mandibular positioning. Additionally, numerous designs of proximal segment positioning devices have been published, but comparative studies on their effectiveness have not been conducted. Therefore, a study comparing these approaches has been planned

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: June 4, 2024
• Study Start: October 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)