Study of jaw function after injection of platelet-rich fibrin into the jaw joint in people with temporomandibular disorders
| ISRCTN | ISRCTN65774128 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65774128 |
| Sponsor | University Clinical Center of Kosovo |
| Funder | Investigator initiated and funded |
- Submission date
- 14/08/2026
- Registration date
- 14/08/2026
- Last edited
- 14/08/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Temporomandibular disorders are conditions affecting the jaw joints and the muscles involved in jaw movement. They may cause pain, restricted mouth opening, and difficulties with normal jaw function. This study investigated changes in pain, jaw movement and jaw function following intra-articular injection of autologous injectable platelet-rich fibrin (i-PRF) in adults with temporomandibular disorders.
Who can participate?
Patients aged 18–65 years with a temporomandibular disorder
What does the study involve?
Participants received two intra-articular injections of autologous injectable platelet-rich fibrin into the affected temporomandibular joint. The second injection was given 1 week after the first. The i-PRF was prepared from the participant's own venous blood immediately before administration.
Participants were assessed before treatment and during follow-up. Jaw functional limitation, pain intensity and maximum mouth opening were assessed at predefined time points, including 1 week after the first injection, 1 week after the second injection, and subsequent follow-up assessments at 1 month and 3 months after treatment.
What are the possible benefits and risks of participating?
Participants may or may not experience an improvement in jaw pain, mouth opening or jaw function following treatment. As with intra-articular injection procedures, possible risks include temporary pain or discomfort, swelling, bleeding, bruising, infection, or other local reactions. Because the treatment uses the participant's own blood-derived material, the risk of an immune reaction to the injected material is expected to be low.
Where is the study run from?
University Clinical Center of Kosovo (Kosovo)
When is the study starting and how long is it expected to run for?
April 2024 to September 2026
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
1. Dr Venera Bimbashi, vbimbashi@gmail.com
2. Dr Besim Hajdari, besim.hajdari@uni-pr.edu
Contact information
Scientific, Principal investigator, Public
University Clinical Center of Kosovo, Hospital Area
Prishtina
10000
Kosovo
| Phone | +383 (0)44272787 |
|---|---|
| besim.hajdari@uni-pr.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Non-randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | Treatment |
| Scientific title | Functional outcomes following intra-articular injectable platelet-rich fibrin injection in patients with temporomandibular disorders: a prospective single-arm interventional clinical study |
| Study acronym | iPRF-TMD |
| Study objectives | Temporomandibular disorders are common conditions affecting the temporomandibular joint and associated structures and may cause pain, restricted jaw movement, and impaired mandibular function. Injectable platelet-rich fibrin is an autologous blood-derived biomaterial containing platelets and leukocytes and has been proposed as a biological treatment to support tissue healing and reduce symptoms associated with temporomandibular disorders. The primary aim of the study was to evaluate changes in functional outcomes following intra-articular injectable platelet-rich fibrin treatment in patients with temporomandibular disorders. The study was not prospectively registered because, at the time of study initiation and participant enrollment, the investigators were unaware that prospective registration was required for this type of interventional clinical study. The study is being registered retrospectively to provide transparent public documentation of the study design and conduct. |
| Ethics approval(s) |
Approved 08/05/2023, Ethics committee of the Faculty of Medicine, University of Prishtina (Faculty of Medicine University of Prishtina “Hasan Prishtina”, Bulevardi i Dëshmorëve, p.n., Prishtina, 10000, Kosovo; +383 (0)38 512 221; mjekesia@uni-pr.ed), ref: 3698/2023 |
| Health condition(s) or problem(s) studied | Temporomandibular disorders (TMD), including temporomandibular joint dysfunction and associated limitations in jaw function |
| Intervention | Participants received intra-articular injections of autologous injectable platelet-rich fibrin (i-PRF) for the treatment of temporomandibular disorders. For preparation of i-PRF, 13 ml of peripheral venous blood was collected from each participant and processed using a Duo Quattro PRF centrifuge at 700 rpm for 3 minutes. The resulting injectable platelet-rich fibrin was prepared immediately before administration. The i-PRF was administered intra-articularly into the affected temporomandibular joint using a sterile 30-gauge needle. Each participant received two intra-articular injections, with the second injection administered 1 week after the first. The injection procedure was performed under aseptic conditions following disinfection of the injection site with povidone-iodine (Betadine). |
| Intervention type | Biological/Vaccine |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Autologous injectable platelet-rich fibrin (i-PRF) |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 11/09/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 68 |
| Total final enrolment | 68 |
| Key inclusion criteria | 1. Adult patients with a clinical diagnosis of temporomandibular disorders (TMD) based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) 2. Presented with pain associated with disco-condylar incoordination (disc displacement with or without locking, clicking, or crepitation) and persistent temporomandibular joint (TMJ) and/or masticatory muscle pain refractory to at least 4 weeks of conservative management, including analgesics, occlusal splint therapy, or physiotherapy 3. All participants were required to be willing to undergo i-PRF treatment and adhere to the follow-up protocol |
| Key exclusion criteria | 1. Patients diagnosed with TMJ osteoarthritis, articular disc perforation, growth disorder syndromes, infectious arthritis, or bilateral arthralgia 2. Pregnant 3. History of previous TMJ surgical interventions 4. Presented with systemic conditions that could impair soft or hard tissue healing 5. Patients with contraindications to platelet-rich fibrin therapy, such as fibrin deficiency, platelet function disorders, or current anticoagulant therapy |
| Date of first enrolment | 15/04/2024 |
| Date of final enrolment | 11/06/2026 |
Locations
Countries of recruitment
- Kosovo
Study participating centre
Hospital Area
Prishtina
10000
Kosovo
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
14/08/2026: Study's existence confirmed by the ethics committee of the Faculty of Medicine, University of Prishtina.
