TMJ Disc DisorderNCT06766851
Evaluation of the Effectiveness of Arthrocentesis Using Catheter in the Treatment of Temporamandibular Joint Disorders
A study testing Procedure: TMJ Arthrocentesis in people with TMJ Disc Disorder and Treatment, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
The study focused on arthrocentesis performed using a catheter, aiming to assess its effects on pain perception and mouth opening in patients with TMJ disorders. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- TMJ Disc Disorder, Treatment, Arthrocentesis
- What is being tested?
- Procedure: TMJ Arthrocentesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jan 2025to 15 Apr 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Patients included in this study were adult individuals aged 18 years and older who were diagnosed with stage 3 or higher temporomandibular joint (TMJ) disorder according to the Wilkes classification, based on magnetic resonance imaging (MRI) in addition to clinical evaluation. Eligible patients had unilateral internal TMJ disorder and exhibited clinical symptoms such as TMJ-related pain and/or joint sounds, and limited mouth opening. Furthermore, only patients whose symptoms persisted despite at least one month of occlusal splint therapy were included.
Exclusion criteria were as follows: patients diagnosed with myofascial pain or muscle-related functional limitation; those who had previously undergone intra-articular injection or other invasive procedures involving the TMJ; patients with connective tissue diseases such as rheumatoid arthritis or with neurological disorders; patients with a history of major jaw trauma; and individuals with psychiatric disorders or a history of substance abuse.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskişehir Osmangazi University
Eskişehir, 26480
About this study
Official title: Comparison of Single-Needle Arthrocentesis and Intravenous Catheter-Assisted Arthrocentesis in the Management of Temporomandibular Joint Disorders
The study focused on arthrocentesis performed using a catheter, aiming to assess its effects on pain perception and mouth opening in patients with TMJ disorders.
Read the detailed description
Two groups will be formed consisting of patients who present with complaints of TMJ pain, limited mouth opening and hearing sounds in the joint and are diagnosed with TMJ disorder. After explaining the I-PRF protocol obtained by taking blood to both groups and obtaining the necessary consents, arthrocentesis will be performed on the relevant joint area using a catheter for the patients in the first group and a single needle for the patients in the second group. Patients will be called for check-ups on the 1st day, 1st week and 1st month after the protocols and the current perceived pain level before and after the treatment will be determined by scoring with Visual Analog Scala (VAS) and measuring the mouth opening with a ruler ( mm).
- Conditions
- TMJ Disc Disorder, Treatment, Arthrocentesis
- Being tested
- Procedure: TMJ Arthrocentesis
- Keywords
- Branul
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: TMJ ArthrocentesisOther
Temporomandibular joint arthrocentesis
| Study group | Role | What they receive |
|---|---|---|
| Catheter group | Experimental | Patients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with catheter arthrocentesis. The upper joint space was entered with a 16 gauge 45 mm long branul. The 16 gauge metal cannula was removed and the plastic sheath was left in the upper joint space. The 18 gauge metal cannula, which was 1 size smaller, was placed inside the sheath. The irrigation solution was administered through the 18 gauge metal cannula and the irrigation solution flowed out of the space between the cannula and the sheath + I-PRF Receives: Other: Procedure: TMJ Arthrocentesis |
| conventional single needle group | Active comparator | Patients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with single puncture arthrocentesis + I-PRF Receives: Other: Procedure: TMJ Arthrocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurement of pain-free maximum mouth opening (MMO) in millimeters
Pain-free MMO was measured as the distance between the incisal edges of the upper and lower incisors while patient's mouth is open as possible without any assistance and without pain. Three measurements were performed, and their average is recorded.
Measured: Preopretive, Postoperative 1st day, 1st week and 1st month
Change in post-operative pain assessed
A visual analog scale (VAS) was used, grading from 0 to 10 (0: no pain, 10: unbearable pain)
Measured: Preoperative, Postoperative 1st day, 1st week and 1st month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start13 Jan 2025
- Primary completion15 Mar 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TMJ Disc DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gorkem Tekin, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766851
- Sponsor's protocol ID
- EskisehirOU-TEKIN-002
- Status last verified
- Oct 2026
- First submitted
- 4 Jan 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hasanoglu Erbasar GN, Senturk MF, Sancak K. The Short-Term Results of the Modified Concentric-Needle Technique for Single-Puncture Arthrocentesis: A Preliminary Study. J Coll Physicians Surg Pak. 2024 Jun;34(6):717-722. doi: 10.29271/jcpsp.2024.06.717.
PubMed 38840358Senturk MF, Yazici T, Gulsen U. Techniques and modifications for TMJ arthrocentesis: A literature review. Cranio. 2018 Sep;36(5):332-340. doi: 10.1080/08869634.2017.1340226. Epub 2017 Jun 15.
PubMed 28618972
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Single-Needle Arthrocentesis and Intravenous Catheter-Assisted Arthrocentesis in the Management of Temporomandibular Joint Disorders
- ClinicalTrials.gov ID
- NCT06766851
- Acronym / sponsor ID
- EskisehirOU-TEKIN-002
- Conditions
- TMJ Disc Disorder, Treatment, Arthrocentesis
- Keywords
- Branul
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study focused on arthrocentesis performed using a catheter, aiming to assess its effects on pain perception and mouth opening in patients with TMJ disorders.
Detailed description
Two groups will be formed consisting of patients who present with complaints of TMJ pain, limited mouth opening and hearing sounds in the joint and are diagnosed with TMJ disorder. After explaining the I-PRF protocol obtained by taking blood to both groups and obtaining the necessary consents, arthrocentesis will be performed on the relevant joint area using a catheter for the patients in the first group and a single needle for the patients in the second group. Patients will be called for check-ups on the 1st day, 1st week and 1st month after the protocols and the current perceived pain level before and after the treatment will be determined by scoring with Visual Analog Scala (VAS) and measuring the mouth opening with a ruler ( mm).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter group | Experimental | Other: Procedure: TMJ ArthrocentesisPatients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with catheter arthrocentesis. The upper joint space was entered with a 16 gauge 45 mm long branul. The 16 gauge metal cannula was removed and the plastic sheath was left in the upper joint space. The 18 gauge metal cannula, which was 1 size smaller, was placed inside the sheath. The irrigation solution was administered through the 18 gauge metal cannula and the irrigation solution flowed out of the space between the cannula and the sheath + I-PRF |
| conventional single needle group | Active comparator | Other: Procedure: TMJ ArthrocentesisPatients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with single puncture arthrocentesis + I-PRF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procedure: TMJ ArthrocentesisTemporomandibular joint arthrocentesis | Other | Catheter group, conventional single needle group |
Primary outcome
The measurement of pain-free maximum mouth opening (MMO) in millimeters
Time frame: Preopretive, Postoperative 1st day, 1st week and 1st month
Pain-free MMO was measured as the distance between the incisal edges of the upper and lower incisors while patient's mouth is open as possible without any assistance and without pain. Three measurements were performed, and their average is recorded.
Change in post-operative pain assessed
Time frame: Preoperative, Postoperative 1st day, 1st week and 1st month
A visual analog scale (VAS) was used, grading from 0 to 10 (0: no pain, 10: unbearable pain)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Results publication: PubMed 38840358Hasanoglu Erbasar GN, Senturk MF, Sancak K. The Short-Term Results of the Modified Concentric-Needle Technique for Single-Puncture Arthrocentesis: A Preliminary Study. J Coll Physicians Surg Pak. 2024 Jun;34(6):717-722. doi: 10.29271/jcpsp.2024.06.717.
- Results publication: PubMed 28618972Senturk MF, Yazici T, Gulsen U. Techniques and modifications for TMJ arthrocentesis: A literature review. Cranio. 2018 Sep;36(5):332-340. doi: 10.1080/08869634.2017.1340226. Epub 2017 Jun 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: TMJ Arthrocentesis in people with TMJ Disc Disorder and Treatment, run by Eskisehir Osmangazi 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?
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 16 Oct 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?
The measurement of pain-free maximum mouth opening (MMO) in millimeters (time frame: Preopretive, Postoperative 1st day, 1st week and 1st month). 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?
On the ClinicalTrials.gov record for NCT06766851, which also lists 2 linked publications.
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 16 Oct 2026.