Orthognathic Surgery
Conditions
Keywords
virtual surgical planning, Le fort 1, PSSO
Brief summary
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.
Detailed description
In orthognathic surgery cases, maxillary repositioning in three dimensions can be obtained. Recently using the custom-made plates instead of wafer used in classic models can get an accurate plan transfer, however it can get suboptimal accurate repositioning. The aim of the study is to evaluate the accuracy of two customized titanium plates versus four customized titanium plates in transferring the virtual plan in orthognathic surgeries.
Interventions
PROCEDUREtwo customized titanium plates
two customized titanium plates for virtual plan transfer in orthognathic surgery for accurate plan transfer to the surgical field
PROCEDUREfour customized titanium plates
four customized titanium plates for virtual plan transfer in orthognathic surgery for accurate plan transfer to the surgical field
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
two customized titanium plates for virtual plan transfer in orthognathic surgery
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
.Patients with dentofacial disharmony and misalignment requiring orthognathic surgeries. * Patients with no signs or symptoms of active TMDs. * Highly motivated patients.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| assessment of the accuracy of plan transfer | within one week | 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
| Measure | Time frame | Description |
|---|---|---|
| patient satisfaction | 6 months | 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. |
Countries
Egypt
Contacts
CONTACTMohamed Gamal Hammad, master degree
Outcome results
None listed