RecruitingNot ApplicableNCT06442787

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


Sponsor

Bezmialem Vakif University

Enrollment

60 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria3

  • 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

Exclusion Criteria10

  • 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

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Interventions

DEVICEconventional splints

only intermediate and final splint will be used during the surgery

DEVICEcutting guides and positioning guides

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

DEVICEcutting guides and fixation plates

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


Locations(1)

Bezmialem Vakıf Universty

Istanbul, Fatih, Turkey (Türkiye)

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NCT06442787


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