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Blood-derived biomaterial for lower jaw surgery

Evaluation of platelet-rich fibrin effectiveness in contour defect modelling in orthognathic surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10296235
Enrollment
50
Registered
2024-05-30
Start date
2020-09-10
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of mandibular lower border defects after bilateral sagittal split osteotomy Surgery

Interventions

Patients are randomly allocated to study and control groups by stratified randomisation method using a computer program. Patients know their allocated groups. Before surgery, peripheral venous blood

Sponsors

Riga Stradinš University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Patients who did not have cone-beam computed tomography 7-12 days and 1 year after surgery

Design outcomes

Primary

MeasureTime frame
1. Presence/absence of inferior border bone defects at the mandible near the vertical osteotomy site measured using CBCT at 1 year after surgery 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

MeasureTime frame
1. Bone resorption/remodelling near the osteotomy site measured using CBCT at 7-12 days and 1 year after surgery 2. Concentration of proteins in i-PRF and their correlation at 1-2 days before surgery: 2.1. EGF (pg/ml) measured using ELISA assay 2.2. VEGF (pg/ml) measured using ELISA assay 2.3. PDGF (pg/ml) measured using ELISA assay 2.4. TGFb1 (pg/ml) measured using ELISA assay 2.5. IL8 (pg/ml) measured using ELISA assay 3. The anti-microbial effect of i-PRF measured using the agar-diffusion method, zone of inhibition (mm) at 1-2 days before surgery

Countries

Latvia

Contacts

Public ContactLana Micko
lana.micko@rsu.lv+371 (0)26123251

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026