Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
All Genders
Healthy Volunteers
ID06442787

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

Led by Bezmialem Vakif University · Updated on 2025-01-28

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating different methods to improve the accuracy of mandibular positioning during orthognathic surgery, which corrects dentofacial deformities. This study focuses on comparing conventional splints, patient-specific cutting and positioning guides, and patient-specific fixation plates. The goal is to determine the best approach to reduce errors in positioning the mandibular proximal segment and to understand how these methods affect condylar changes after surgery. The study involves three groups of participants undergoing bilateral sagittal split osteotomy. One group uses only conventional intermediate and final splints during surgery. The second group uses patient-specific cutting and positioning guides, while the third group uses patient-specific cutting guides and fixation plates. These patient-specific devices are designed using virtual surgical planning to precisely transfer the surgical plan to the operation. The trial compares the accuracy and outcomes of these approaches. Participants will be assessed for mandibular condyle changes within the first week after surgery, which is the primary outcome measure. The accuracy of virtual surgical planning will also be evaluated as a secondary outcome during this period. The study includes healthy adults aged 18 to 55 with skeletal Class 2 or Class 3 malocclusion who have completed orthodontic treatment. Data collection includes postoperative CT scans and monitoring for complications. The total involvement includes surgery and immediate postoperative assessment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Patients with cleft lip and palate or craniofacial deformities
  • Oligodontia
  • Patients unable to continue study due to intraoperative complications or missing postoperative CT scans
  • Patients with pre-existing temporomandibular joint disorders
  • Patients with 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and the first week after surgery

Participants undergo orthognathic surgery using either conventional splints, patient-specific cutting and positioning guides, or patient-specific cutting guides and fixation plates to correct dentofacial deformities.

1 surgical visit and approximately 1 week of post-operative monitoring visits

Post-operative Follow-up

Duration - 1 week

Participants are monitored for mandibular condyle changes and to assess the accuracy of the virtual surgical planning during the first week after surgery.

Multiple visits in the first week after surgery

Trial Site Locations

Total: 1 location

1

Bezmialem Vakıf Universty

Istanbul, Fatih, Turkey (Türkiye), 34093

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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