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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBezmialem Vakif University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • conventional splints

    Device

    only intermediate and final splint will be used during the surgery

  • cutting guides and positioning guides

    Device

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

  • cutting guides and fixation plates

    Device

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

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: control groupExperimental treatment 1 intervention
Group B: group 2Active comparator 1 intervention
Group C: group 3Active comparator 1 intervention

Trial outcomes

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.

Time frame
in the first week after the surgery

Secondary outcomes

1

Rate of the virtual surgical planning accuracy

Postoperative CT data will be transferred to Mimics (Materialise, Belgium, v21) software in DICOM format. Here, a 3D head and jaw model will be obtained from this data. For this purpose, 24 cephalometric points will be selected in both models. In this software, an analysis containing these points will be created and the 2-dimensional linear distances between the preoperative and postoperative positions of these points will be calculated. The accuracy between preoperative and postoperative models will be evaluated in the Mimics software.

Time frame
in the first week after the surgery

Other outcomes

Sponsors and contacts

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