Blood-derived biomaterial for lower jaw surgery
| ISRCTN | ISRCTN10296235 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10296235 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nr. 6-1/09/8 |
| Sponsor | Riga Stradiņš University |
| Funder | Rīgas Stradiņa Universitāte |
- Submission date
- 11/05/2024
- Registration date
- 30/05/2024
- Last edited
- 04/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Orthognathic surgery is a common treatment approach for severe dentofacial deformities, which is done for repositioning the jaws when there is an incorrect position, shape, or size of the jaw. After large mandibular (jaw) movement during bilateral sagittal split osteotomy (BSSO) surgery, insufficient bone contact may result in compromised bone healing. Injectable platelet-rich fibrin (PRF) can be made from the patient's own blood to stimulate bone formation. The study aims to evaluate the use of PRF in orthognathic surgery in comparison to conventional orthognathic surgery.
Who can participate?
Patients aged 18-50 years with diagnosed dentofacial deformities who are undergoing bilateral sagittal split osteotomy (BSSO) surgery
What does the study involve?
Patients are assigned randomly to one of two groups – the study group and the control group. Control group patients undergo conventional BSSO. Study group patients provide blood samples 1-2 days before surgery for i-PRF preparation and laboratory analysis. Study group patients undergo BSSO, but during surgery prepared i-PRF is applied. At 7-12 days and 1 year after surgery all patients undergo CT scans.
What are the possible benefits and risks of participating?
The use of i-PRF can lead to improved surgical results leading to improved aesthetic results and patient satisfaction with surgery.
The researchers do not expect any significant risks as i-PRF is made from the patient's own blood.
Where is the study run from?
Riga Stradins University Institute of Stomatology (Latvia)
When is the study starting and how long is it expected to run for?
July 2020 to March 2025
Who is funding the study?
Riga Stradins University Institute of Stomatology (Latvia)
Who is the main contact?
Dr Lana Micko, lana.micko@gmail.com, lana.micko@rsu.lv, lana.micko@rsusi.lv
Contact information
Public, Scientific, Principal investigator
Dzirciema iela 20
Riga
LV-1007
Latvia
 ORCID ID |
0000-0001-9408-162X |
|---|---|
| Phone | +371 (0)26123251 |
| lana.micko@rsu.lv |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center interventional study randomized controlled trial. |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Evaluation of platelet-rich fibrin effectiveness in contour defect modelling in orthognathic surgery |
| Study objectives | The use of platelet-rich fibrin (PRF) promotes newly formed bone volume increase in orthognathic surgery contour defect sites in comparison to conventional orthognathic surgery. |
| Ethics approval(s) |
Approved 10/09/2020, Riga Stradins University Research Ethics Committee (Dzirciema iela 16, Riga, LV-1007, Latvia; +371 (0)67061547; pek@rsu.lv), ref: Nr. 6-1/09/8 |
| Health condition(s) or problem(s) studied | Prevention of mandibular lower border defects after bilateral sagittal split osteotomy |
| Intervention | 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 samples were collected from study group patients. Blood samples are used to prepare i-PRF using centrifugation for further i-PRF testing in the laboratory. ELISA assays are used according to the protocol to find the concentration of EGF, VEGF, PDGF, TGF1, and IL-8 in i-PRF. i-PRF samples are also used for anti-microbial tests against different microorganisms. Bilateral sagittal split osteotomy (BSSO) surgery is carried out for control and study group patients. Study group patients during the surgery receive i-PRF, applied in osteotomy sites, i-PRF is prepared during the surgery from patients’ venous blood samples. 1-2 weeks after surgery surgical results are evaluated using cone-beam computed tomography (CBCT). CBCT is also done 1 year after the surgery. Both CBCTs are analyzed using digital subtraction analysis and newly formed bone volume is measured at the vertical osteotomy site. After all data is obtained statistical analysis is done. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Presence/absence of inferior border bone defects at the mandible near the vertical osteotomy site measured using CBCT at 1 year after surgery |
| Key secondary outcome measure(s) |
1. Bone resorption/remodelling near the osteotomy site measured using CBCT at 7-12 days and 1 year after surgery |
| Completion date | 03/03/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Total final enrolment | 40 |
| Key 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 |
| Key exclusion criteria | Patients who did not have cone-beam computed tomography 7-12 days and 1 year after surgery |
| Date of first enrolment | 10/09/2020 |
| Date of final enrolment | 06/02/2024 |
Locations
Countries of recruitment
- Latvia
Study participating centres
Riga
LV-1007
Latvia
Riga
LV-1002
Latvia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated and analysed during the current study will be available upon request from Dr Lana Micko (lana.micko@gmail.com; lana.micko@rsu.lv) The type of data that will be shared: i-PRF obtaining and processing protocol for application in surgery, i-PRF obtaining and processing protocol for ELISA assay, and primary and secondary outcome measurements. Dates of availability: 5 years after the end of the study. Whether consent from participants was required and obtained: consent from study participants was required and obtained. Comments on data anonymization: data are anonymized according to the European General Data Protection Regulation (GDPR). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/08/2025 | 04/08/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/08/2025: Publication reference added.
07/08/2024: Total final enrolment added.
02/08/2024: Sponsor contact details updated.
13/05/2024: Study's existence confirmed by the Riga Stradins University Research Ethics Committee.
