Assessing a new method for jaw surgery without splints
Radiographic Assessment of Three Dimensional Mandibular Position Using Splint-less Patient Specific Implant Following Bilateral Sagittal Split Osteotomy
This study tests a new way to do jaw surgery without using splints to see if it can improve the accuracy and results for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06160661 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a splint-less approach for orthognathic surgery of the jaw using a personalized surgical guide system. The method involves the use of custom titanium fixation plates and cutting guides to perform bilateral sagittal split osteotomies (BSSOs) without traditional surgical splints. The accuracy of this technique is assessed by comparing planned surgical outcomes with actual postoperative results through detailed measurements of discrepancies in jaw positioning. The goal is to improve surgical precision and patient outcomes in jaw surgeries.
Who should consider this trial
Good fit: Ideal candidates are patients with skeletal deformities requiring mandibular orthognathic surgery who are otherwise healthy.
Not a fit: Patients with metabolic bone diseases or those who have undergone radiotherapy in the head and neck region may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and efficient jaw surgeries with potentially quicker recovery times for patients.
How similar studies have performed: While similar approaches have been explored, this specific splint-less method using personalized implants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients suffering from skeletal deformity requiring mandibular orthognathic surgery (Bilateral sagittal splitting osteotomy). 2. Patients should be free from any systemic disease that may affect normal bone healing and predictable outcome. Exclusion Criteria: 1. Patients with metabolic bone disease that affects bone healing. 2. Intra-bony lesions that may affect the osteotomy healing. 3. Patients with history of radiotherapy on the head and neck region
Where this trial is running
Cairo
- Faculty of Dentistry — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: abanoub Aziz, PhDcandidate
- Email: abanoubfayez@dent.asu.edu.eg
- Phone: 020 01202248330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.