Comparison of Hyaluronic Acid, Injectable Platelet-Rich Fibrin, and Prolotherapy in TMJ Arthrocen… (NCT07479693) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Hyaluronic Acid, Injectable Platelet-Rich Fibrin, and Prolotherapy in TMJ Arthrocentesis
Turkey (Türkiye)36 participantsStarted 2025-01-01
Plain-language summary
This study aimed to compare the clinical effectiveness of different intra-articular adjunctive therapies used with temporomandibular joint (TMJ) arthrocentesis in patients with temporomandibular joint disorders. TMJ arthrocentesis is a minimally invasive procedure commonly used to reduce pain and improve mandibular function in patients with internal derangements of the temporomandibular joint. In this study, patients diagnosed with TMJ disorders were treated with arthrocentesis alone or arthrocentesis combined with intra-articular injection of hyaluronic acid, injectable platelet-rich fibrin (i-PRF), or dextrose prolotherapy. Clinical outcomes including pain intensity, mandibular range of motion, and functional improvement were evaluated at different follow-up periods. The aim of this study was to compare the effectiveness of these adjunctive treatments and to determine whether any of these intra-articular approaches provides superior clinical outcomes when used with TMJ arthrocentesis.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients presenting with temporomandibular joint (TMJ) pain, limited mouth opening, and/or unilateral joint pain
* Patients diagnosed with internal derangement of the temporomandibular joint classified as DC/TMD
* Patients who did not respond adequately to conservative treatment modalities
* Patients who underwent temporomandibular joint magnetic resonance imaging (MRI) evaluation
* Individuals aged 18-65 years
Exclusion Criteria:
* Individuals who did not provide informed consent or were unwilling to participate in the study
* Patients whose primary source of pain was myofascial pain dysfunction or cervical-origin pain
* Pregnant or breastfeeding patients
* Patients with a known allergy to any of the injected solutions used in the study
* Patients with systemic joint diseases such as rheumatoid arthritis
* Patients with acute infection in the temporomandibular joint region
* Patients with hematological disorders
* Patients with a history of previous temporomandibular joint surgery
* Patients with tumors or malignant neoplasms involving the temporomandibular joint
* Patients with a history of oral or maxillofacial trauma affecting the temporomandibular joint
* Patients who were unable to cooperate with clinical examination or follow-up procedures
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pain Intensity (Visual Analog Scale, VAS)
Timeframe: Baseline, 1 week, 1 month, and 3 months
2
Change in Maximum Mouth Opening
Timeframe: Baseline, 1 week, 1 month, and 3 months