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Temporomandibular Joint PainNCT07479693

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

A study testing Temporomandibular Joint Arthrocentesis, Hyaluronic Acid (Orthovisc) and Injectable Platelet-Rich Fibrin (i-PRF) in people with Temporomandibular Joint Pain and Arthrocentesis, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Temporomandibular Joint Pain, Arthrocentesis
What is being tested?
Temporomandibular Joint Arthrocentesis, Hyaluronic Acid (Orthovisc) and Injectable Platelet-Rich Fibrin (i-PRF)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2025to 1 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ondokuz Mayis University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

    Samsun, Atakum

Other trials in Turkey (Türkiye)

About this study

Official title: Comparative Evaluation Of Hyaluronic Acid, Injectable Platelet-Rich Fibrin, And Dextrose Prolotherapy As Adjuncts To Temporomandibular Joint Arthrocentesis In Patients With Temporomandibular Joint Disorders

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.

Read the detailed description

Temporomandibular joint (TMJ) disorders represent a heterogeneous group of conditions affecting the temporomandibular joint, masticatory muscles, and associated structures. These disorders are among the most common causes of chronic orofacial pain and functional impairment. Patients with temporomandibular joint disorders frequently present with symptoms such as joint pain, limited mouth opening, joint sounds, and impaired mandibular movements, which may significantly affect quality of life. The pathophysiology of TMJ disorders is multifactorial and may involve internal derangements of the joint, inflammatory processes, biomechanical alterations, and degenerative changes within the joint structures.

Conservative treatment approaches, including patient education, pharmacologic therapy, occlusal splints, and physiotherapy, are generally considered the first-line management for temporomandibular joint disorders. However, a subset of patients may not achieve adequate symptom relief with conservative treatment. In such cases, minimally invasive surgical procedures, such as temporomandibular joint arthrocentesis, are frequently recommended. Arthrocentesis is a minimally invasive procedure that involves lavage of the superior joint space to remove inflammatory mediators, release adhesions, reduce intra-articular pressure, and improve joint mobility. This technique has been widely used in the management of internal derangements and other temporomandibular joint pathologies and has demonstrated favorable clinical outcomes in terms of pain reduction and functional improvement.

In recent years, several intra-articular adjunctive therapies have been introduced to enhance the therapeutic effects of TMJ arthrocentesis. Hyaluronic acid is one of the most commonly used agents due to its viscoelastic, lubricating, and anti-inflammatory properties. Intra-articular hyaluronic acid injections may help restore the physiological properties of synovial fluid, improve joint lubrication, and contribute to pain reduction and functional recovery. Injectable platelet-rich fibrin (i-PRF) is an autologous platelet concentrate that contains a high concentration of growth factors and cytokines that may promote tissue healing, angiogenesis, and regenerative processes within the joint structures. Dextrose prolotherapy has also gained interest as a regenerative injection therapy that may stimulate fibroblast activity, enhance connective tissue repair, and potentially improve joint stability and function.

Although these intra-articular treatment modalities have been increasingly used in clinical practice, the available evidence regarding their comparative effectiveness when used in conjunction with TMJ arthrocentesis remains limited. Most previous studies have evaluated these therapies separately, and there is a lack of prospective comparative studies assessing different intra-articular adjuncts within the same clinical study design.

The aim of this study was to compare the clinical outcomes of temporomandibular joint arthrocentesis performed alone and arthrocentesis combined with different intra-articular adjunctive treatments, including hyaluronic acid, injectable platelet-rich fibrin (i-PRF), and dextrose prolotherapy. Patients diagnosed with temporomandibular joint disorders and presenting with joint pain and functional limitation were included in the study according to predefined inclusion and exclusion criteria. Following clinical and radiological evaluation, eligible patients were allocated into four treatment groups: arthrocentesis alone, arthrocentesis combined with hyaluronic acid injection, arthrocentesis combined with injectable platelet-rich fibrin (i-PRF), and arthrocentesis combined with dextrose prolotherapy.

All procedures were performed under standardized clinical conditions. Temporomandibular joint arthrocentesis was carried out using a conventional two-needle technique to irrigate the superior joint space. Following lavage, the designated intra-articular agent was administered according to the treatment group. Clinical outcomes were evaluated using standardized parameters including pain intensity assessed by visual analog scale (VAS), maximum mouth opening, and functional improvement of mandibular movements. Patients were followed at predefined postoperative intervals, and the changes in clinical parameters were analyzed to assess treatment effectiveness.

The results of this study are expected to provide comparative clinical data regarding the effectiveness of different intra-articular adjunctive therapies used with temporomandibular joint arthrocentesis. The findings may contribute to the current evidence base and assist clinicians in selecting the most appropriate minimally invasive treatment strategy for patients with temporomandibular joint disorders.

Being tested
Temporomandibular Joint Arthrocentesis, Hyaluronic Acid (Orthovisc), Injectable Platelet-Rich Fibrin (i-PRF), Dextrose prolotherapy (DPT)
Keywords
Injectable Platelet-Rich Fibrin, Prolotherapy, Hyaluronic Acid, Temporomandibular Joint Arthrocentesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Temporomandibular Joint ArthrocentesisProcedure or surgery

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

  • Hyaluronic Acid (Orthovisc)Drug

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

  • 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.

  • Dextrose prolotherapy (DPT)Drug

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

Study groups in NCT07479693
Study groupRoleWhat they receive
Arthrocentesis AloneActive comparatorParticipants 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.
Receives: Procedure: Temporomandibular Joint Arthrocentesis
Arthrocentesis + Hyaluronic AcidExperimentalParticipants in this group underwent temporomandibular joint arthrocentesis followed by intra-articular injection of hyaluronic acid (Orthovisc) after the lavage procedure.
Receives: Procedure: Temporomandibular Joint Arthrocentesis; Drug: Hyaluronic Acid (Orthovisc)
Arthrocentesis + Injectable Platelet-Rich FibrinExperimentalParticipants 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.
Receives: Procedure: Temporomandibular Joint Arthrocentesis; Biological: Injectable Platelet-Rich Fibrin (i-PRF)
Arthrocentesis + Dextrose ProlotherapyExperimentalParticipants in this group underwent temporomandibular joint arthrocentesis followed by intra-articular injection of dextrose solution administered as prolotherapy.
Receives: Procedure: Temporomandibular Joint Arthrocentesis; Drug: Dextrose prolotherapy (DPT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 1 week, 1 month, and 3 months

  2. 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.

    Measured: Baseline, 1 week, 1 month, and 3 months

Secondary outcomes (3)
  1. Change in Jaw Functional Limitation Scale Score (JFLS-8)

    Functional limitation assessed using the 8-item Jaw Functional Limitation Scale (JFLS-8). Each item is scored on a 0-10 numeric rating scale, where 0 indicates no functional limitation and 10 indicates severe functional limitation. Higher scores indicate greater functional impairment.

    Measured: 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.)

  2. Change in Graded Chronic Pain Scale Score (GCPS 2.0)

    Pain-related disability assessed using the Graded Chronic Pain Scale version 2.0 (GCPS 2.0). The scale evaluates chronic pain intensity and pain-related disability. Higher scores represent greater pain severity and functional disability.

    Measured: 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.)

  3. Change in Pain Drawing Score

    Pain distribution assessed using the Pain Drawing Questionnaire, where patients mark painful areas on a standardized body diagram. Larger marked areas indicate wider pain distribution.

    Measured: Baseline, 1 week, 1 month, and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2026
  2. Study start1 Jan 2025
  3. Primary completion1 Aug 2025
  4. Study completion1 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07479693
Sponsor's protocol ID
OMU-OMFS-TMJ-2026-01
Other IDs
BAP04-B-2024-4944
Status last verified
Mar 2026
First submitted
9 Mar 2026
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Temporomandibular Joint Arthrocentesis, Hyaluronic Acid (Orthovisc) and Injectable Platelet-Rich Fibrin (i-PRF) in people with Temporomandibular Joint Pain and Arthrocentesis, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Intensity (Visual Analog Scale, VAS) (time frame: Baseline, 1 week, 1 month, and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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