Blood-derived biomaterial for lower jaw surgery
Not Applicable
- Conditions
- Prevention of mandibular lower border defects after bilateral sagittal split osteotomySurgery
- Registration Number
- ISRCTN10296235
- Lead Sponsor
- Riga Stradinš University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
1. Aged 18-50 years
2. Patients diagnosed with dentofacial deformities, who were planned to undergo bilateral sagittal split osteotomy
3. A serum vitamin D level of more than 30 ng/ml is considered sufficient thereby patients were included in the study
4. Health condition - without any chronic disease, had no regular medication intake, had no abnormal nicotine or alcohol use
Exclusion Criteria
Patients who did not have cone-beam computed tomography 7-12 days and 1 year after surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Presence/absence of inferior border bone defects at the mandible near the vertical osteotomy site measured using CBCT at 1 year after surgery<br>2. Newly formed bone volume at the site of BSSO vertical osteotomy site measured using CBCT at 7-12 days and 1 year after orthognathic surgery
- Secondary Outcome Measures
Name Time Method 1. Bone resorption/remodelling near the osteotomy site measured using CBCT at 7-12 days and 1 year after surgery<br>2. Concentration of proteins in i-PRF and their correlation at 1-2 days before surgery:<br>2.1. EGF (pg/ml) measured using ELISA assay<br>2.2. VEGF (pg/ml) measured using ELISA assay<br>2.3. PDGF (pg/ml) measured using ELISA assay<br>2.4. TGFb1 (pg/ml) measured using ELISA assay<br>2.5. IL8 (pg/ml) measured using ELISA assay<br>3. The anti-microbial effect of i-PRF measured using the agar-diffusion method, zone of inhibition (mm) at 1-2 days before surgery