ISRCTN ISRCTN10296235
DOI https://doi.org/10.1186/ISRCTN10296235
Secondary identifying numbers Nr. 6-1/09/8
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Lana Micko
Public, Scientific, Principal Investigator

Dzirciema iela 20
Riga
LV-1007
Latvia

ORCiD logoORCID ID 0000-0001-9408-162X
Phone +371 (0)26123251
Email lana.micko@rsu.lv

Study information

Study designSingle-center interventional study randomized controlled trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Dental clinic, Hospital, Laboratory, University/medical school/dental school
Study typePrevention, Efficacy
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleEvaluation of platelet-rich fibrin effectiveness in contour defect modelling in orthognathic surgery
Study objectivesThe 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) studiedPrevention of mandibular lower border defects after bilateral sagittal split osteotomy
InterventionPatients 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, TGF1, 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 typeOther
Primary outcome measure1. 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 outcome measures1. 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
Overall study start date01/07/2020
Completion date03/03/2025

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit50 Years
SexBoth
Target number of participants50
Total final enrolment40
Key inclusion criteria1. 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 criteriaPatients who did not have cone-beam computed tomography 7-12 days and 1 year after surgery
Date of first enrolment10/09/2020
Date of final enrolment06/02/2024

Locations

Countries of recruitment

  • Latvia

Study participating centres

Riga Stradins University Institute of Stomatology
Dzirciema iela 20
Riga
LV-1007
Latvia
Pauls Stradins Clinical University Hospital
Pilsoņu iela 13
Riga
LV-1002
Latvia

Sponsor information

Riga Stradiņš University
Hospital/treatment centre

Institute of Stomatology
Dzirciema iela 20
Riga
LV-1007
Latvia

Phone +371 (0)29420233
Email ieva.svjascenkova@stomatologijasinstituts.lv
Website https://stomatologijasinstituts.lv/
ROR logo "ROR" https://ror.org/03nadks56

Funders

Funder type

University/education

Rīgas Stradiņa Universitāte
Government organisation / Universities (academic only)
Alternative name(s)
Rīga Stradiņš University, Rīga Stradiņš University, Universitas Rigensis Stradina, Riga Medical Institute, Medical Academy of Latvia, RSU
Location
Latvia

Results and Publications

Intention to publish date03/03/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a peer-reviewed journal.
IPD sharing planThe 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

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.