About this trial
In this research the investigators aim to minimize the use of more hardware in the fixation of the orthognathic surgery cases. The objective of this study is to assess the accuracy of the plan transfer with two customized titanium plates versus four customized titanium plates.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients with no signs or symptoms of active TMDs.
Highly motivated patients.
Disqualifiers
Patients who refused to be included in the research.
Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anesthesia.
Patients with intra-bony lesions or infections that may retard the osteotomy healing.
Trial design
Parallel
Treatments tested in this trial
two customized titanium plates
Procedure/Surgerytwo customized titanium plates for virtual plan transfer in orthognathic surgery for accurate plan transfer to the surgical field
four customized titanium plates
Procedure/Surgeryfour customized titanium plates for virtual plan transfer in orthognathic surgery for accurate plan transfer to the surgical field
Treatment groups
Trial outcomes
Primary outcomes
assessment of the accuracy of plan transfer
Specific measurement variable: The skull base in the virtual surgical plan was superimposed using point-based matching ICP registration using anatomical reference points, followed by manual surface-based registration to surface best fit with the skull base in the actual post-operative CBCT scans. The skull base in the virtual surgical plan was superimposed using point-based matching ICP registration using anatomical reference points, followed by manual surface-based registration to surface best fit with the skull base in the actual post-operative CBCT scans.
Secondary outcomes
patient satisfaction
A self-administered OQLQ translated into Arabic will be used to assess quality of life at the recruitment visit and six months after the surgery. Questions 1, 7, 10, 11, and 14 will be about facial aesthetics and appearance, questions 2 to 6 will be about oral function, questions 8, 9, 12, and 13 will be about the awareness of the deformity, and questions 15 to 22 will about the social aspect of the deformity. The questionnaire contains 22 questions, and each question has score from 1 to 4, so each patient will have a score from 22 to 88.
Other outcomes
Bite force
Bite force measurement device by newton
Sponsors and contacts
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