Comparison of Hyaluronic Acid, Injectable Platelet-Rich Fibrin, and Prolotherapy in TMJ Arthrocentesis

NCT07479693 | Completed

• 2 other identifiers: OMU-OMFS-TMJ-2026-01BAP04-B-2024-4944
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Temporomandibular Joint Pain; Arthrocentesis

Keywords

Injectable Platelet-Rich Fibrin; Prolotherapy; Hyaluronic Acid; Temporomandibular Joint Arthrocentesis

Outcome Measures

Primary Outcomes (2)

• Change in Pain Intensity (Visual Analog Scale, VAS)

  Pain intensity was assessed using a Visual Analog Scale (VAS) to evaluate changes in pain levels after temporomandibular joint arthrocentesis alone or in combination with intra-articular hyaluronic acid, injectable platelet-rich fibrin (i-PRF), or dextrose prolotherapy. The Visual Analog Scale (VAS) is presented as a 0-10 numeric rating scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity.

  Baseline, 1 week, 1 month, and 3 months

• Change in Maximum Mouth Opening

  Maximum mouth opening (MMO) was measured clinically in millimeters to evaluate improvement in mandibular mobility after temporomandibular joint arthrocentesis alone or in combination with intra-articular hyaluronic acid, injectable platelet-rich fibrin (i-PRF), or dextrose prolotherapy.

  Baseline, 1 week, 1 month, and 3 months

Secondary Outcomes (3)

• Change in Jaw Functional Limitation Scale Score (JFLS-8)

  Baseline, 1 month, and 3 months (The 1-week assessment was not performed because the questionnaire evaluates symptoms over the preceding month; therefore, a 1-week measurement could cause temporal overlap and affect response interpretation.)

• Change in Graded Chronic Pain Scale Score (GCPS 2.0)

  Baseline, 1 month, and 3 months (The 1-week assessment was not performed because the questionnaire evaluates symptoms over the preceding month; therefore, a 1-week measurement could cause temporal overlap and affect response interpretation.)

• Change in Pain Drawing Score

  Baseline, 1 week, 1 month, and 3 months

Study Arms (4)

Arthrocentesis Alone

ACTIVE COMPARATOR

Participants in this group underwent temporomandibular joint arthrocentesis using the standard two-needle technique. No additional intra-articular agent was administered following the lavage procedure. This group served as the control group for comparison with adjunctive intra-articular treatments.

Procedure: Temporomandibular Joint Arthrocentesis

Arthrocentesis + Hyaluronic Acid

EXPERIMENTAL

Participants in this group underwent temporomandibular joint arthrocentesis followed by intra-articular injection of hyaluronic acid (Orthovisc) after the lavage procedure.

Procedure: Temporomandibular Joint Arthrocentesis; Drug: Hyaluronic Acid (Orthovisc)

Arthrocentesis + Injectable Platelet-Rich Fibrin

EXPERIMENTAL

Participants in this group underwent temporomandibular joint arthrocentesis followed by intra-articular injection of injectable platelet-rich fibrin (i-PRF), an autologous platelet concentrate prepared from the patient's venous blood.

Procedure: Temporomandibular Joint Arthrocentesis; Biological: Injectable Platelet-Rich Fibrin (i-PRF)

Arthrocentesis + Dextrose Prolotherapy

EXPERIMENTAL

Participants in this group underwent temporomandibular joint arthrocentesis followed by intra-articular injection of dextrose solution administered as prolotherapy.

Procedure: Temporomandibular Joint Arthrocentesis; Drug: Dextrose prolotherapy (DPT)

Interventions

Temporomandibular Joint Arthrocentesis PROCEDURE

Temporomandibular joint arthrocentesis was performed using a standard two-needle technique to lavage the superior joint space and remove inflammatory mediators.

Arthrocentesis + Dextrose Prolotherapy; Arthrocentesis + Hyaluronic Acid; Arthrocentesis + Injectable Platelet-Rich Fibrin; Arthrocentesis Alone

Hyaluronic Acid (Orthovisc) DRUG

Intra-articular injection of hyaluronic acid (Orthovisc) into the temporomandibular joint following arthrocentesis.

Arthrocentesis + Hyaluronic Acid

Injectable Platelet-Rich Fibrin (i-PRF) BIOLOGICAL

Autologous injectable platelet-rich fibrin prepared from the patient's venous blood and injected intra-articularly into the temporomandibular joint following arthrocentesis.

Arthrocentesis + Injectable Platelet-Rich Fibrin

Dextrose prolotherapy (DPT) DRUG

Intra-articular injection of dextrose solution administered as prolotherapy into the temporomandibular joint following arthrocentesis.

Arthrocentesis + Dextrose Prolotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

Samsun, Atakum, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Arthrocentesis; Hyaluronic Acid; orthovisc; proliferation regulatory factors, human urine

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Emel Bulut, DDS, PhD

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Oral and Maxillofacial Surgery, Ondokuz Mayis University

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 18, 2026
• Study Start: January 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)