Temporomandibular Disorders (TMD)NCT07327099
Comparative Assessment of Arthrocentesis Methods in TMJ Disorders
A study testing Y-shaped cannula without a source and Y-shaped cannula with a source in people with Temporomandibular Disorders (TMD) and Temporomandibular Joint Disc Displacement, With Reduction, run by Helin Merve Özalp at 1 site in Turkey (Türkiye).
Trial summary
Temporomandibular disorders (TMD) are common conditions in society, characterised by symptoms such as pain, limited movement and joint noises, which negatively affect an individual's quality of life. Read more about this study
- Who is it for?
- Ages 17 to 75 years
- Conditions the study is for
- Temporomandibular Disorders (TMD), Temporomandibular Joint Disc Displacement, With Reduction
- What is being tested?
- Y-shaped cannula without a source and Y-shaped cannula with a source
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 15 Sep 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 17 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with unilateral TME disorders who:
- Are in stages 2-3 of the Wilkes classification
- Have not undergone interventional treatment prior to arthroscopy
- Have undergone conservative treatment prior to arthroscopy without successful results
Who cannot join
- Patients with TME irregularities who have undergone interventional treatment (minimally invasive and invasive)
- Patients with bilateral TME disorders
- Patients with incomplete recorded data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Different Arthrocentesis Techniques in the Treatment of Temporomandibular Joint Disorders
Temporomandibular disorders (TMD) are common conditions in society, characterised by symptoms such as pain, limited movement and joint noises, which negatively affect an individual's quality of life. The primary goal of treatment is to restore the physiological functions of the joint by eliminating the aetiological factors. In cases where conservative methods prove ineffective, arthrocentesis, a minimally invasive approach, comes to the fore. Arthrocentesis aims to reduce pain by removing inflammatory mediators and to increase joint mobility. In this study, the intraoperative parameters and clinical outcomes of different arthrocentesis techniques were compared and evaluated in patients with Wilkes stage 2-3 TME disorders.
Read the detailed description
Introduction: Temporomandibular disorders (TMD) are common symptoms in society, characterized by pain, limited movement, and all sounds, which are often negatively impacted by individual life circumstances. The primary goal of treatment is to eliminate the etiological factors and restore the replaceable functions of the parts. Arthrocentesis, a minimally invasive approach, is emphasized in cases where conservative treatment is beneficial. Arthrocentesis reduces pain by removing inflammatory mediators and increases joint mobility. This effective treatment was evaluated by comparing the intraoperative parameters and clinical success of different arthrocentesis techniques in patients with Wilkes stage 2-3 TMJ disorders.
Materials and Methods: This study is being conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Karadeniz Technical University. Fifty patients (Group 1: n=25, Group 2: n=25) treated with two different arthrocentesis technologies were enrolled retrospectively. The first group was the study of Mun et al. Arthrocentesis was performed using the method employed by Rahal et al., which consisted of two 22-gauge needles bent to form a "Y" shape and placed simultaneously and concentrically. The second group underwent arthrocentesis using a fabricated Y-shaped cannula used by Rahal et al. Each treatment was performed under local anesthesia, and the upper regions were irrigated with an average of 100 ml of Ringer's lactate solution. Following arthrocentesis, 1 ml of hyaluronic acid was injected into the patients. Preoperative and postoperative values were evaluated by comparing the groups at 1 to 6 months. Furthermore, intraoperative arthrocentesis efficiency (number of needle insertions, procedure time, complication rate, and treatment tolerance) was compared between the groups.
- Conditions
- Temporomandibular Disorders (TMD), Temporomandibular Joint Disc Displacement, With Reduction
- Being tested
- Y-shaped cannula without a source, Y-shaped cannula with a source
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-shaped cannula without a sourceProcedure or surgery
Y-shaped cannula without a source Arthrocentesis performed by simultaneously and concentrically placing two manually Y-shaped bent needles into the joint cavity.
Y-shaped cannula with a sourceProcedure or surgery
Y-shaped cannula with a source Arthrocentesis performed by simultaneously and concentrically placing two manually Y-shaped bent needles into the joint cavity.
| Study group | Role | What they receive |
|---|---|---|
| Non-Welded Y-Cannula Group | Active comparator | Group 1: The first group underwent arthrocentesis using a method developed by Mun et al., involving two 22-gauge needles bent to form a Y-shape with their angles facing each other. Receives: Procedure: Y-shaped cannula without a source |
| Welded Y-Cannula Group | Active comparator | Group 2: The second group underwent arthrocentesis using a method developed by Rahal et al., involving a factory-made Y-shaped cannula. Receives: Procedure: Y-shaped cannula with a source |
What is being measured
The primary outcome is the main question the study is designed to answer.
TMJ Pain
TMJ Pain intensity was assessed using the Visual Analog Scale (VAS). The VAS ranges from a minimum score of 1 to a maximum score of 10, where 1 indicates the best condition (no pain) and 10 indicates the worst condition (maximum pain). Higher scores on the scale represent greater pain severity. Accordingly, an increase in the score reflects a higher level of perceived pain by the patients.
Measured: before the procedure, at 1 month and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Aug 2024
- Primary completion15 Aug 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Disorders (TMD)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arthrocentesis was performed on the first group using a method developed by Mun et al., involving two 22-gauge needles bent to form a 'Y' shape with the tips facing each other, and on the second group using a factory-made Y-shaped cannula developed by Rahal et al.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helin Merve Özalp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Helin Merve Özalp, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327099
- Sponsor's protocol ID
- KTU-DHF-HMO-01
- Status last verified
- Apr 2026
- First submitted
- 24 Dec 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared later if required for the confidentiality of the study.
Publications
Senturk 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 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Different Arthrocentesis Techniques in the Treatment of Temporomandibular Joint Disorders
- ClinicalTrials.gov ID
- NCT07327099
- Acronym / sponsor ID
- KTU-DHF-HMO-01
- Conditions
- Temporomandibular Disorders (TMD), Temporomandibular Joint Disc Displacement, With Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Helin Merve ÖzalpUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 8 Jan 2026 (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.
Temporomandibular disorders (TMD) are common conditions in society, characterised by symptoms such as pain, limited movement and joint noises, which negatively affect an individual's quality of life. The primary goal of treatment is to restore the physiological functions of the joint by eliminating the aetiological factors. In cases where conservative methods prove ineffective, arthrocentesis, a minimally invasive approach, comes to the fore. Arthrocentesis aims to reduce pain by removing inflammatory mediators and to increase joint mobility. In this study, the intraoperative parameters and clinical outcomes of different arthrocentesis techniques were compared and evaluated in patients with Wilkes stage 2-3 TME disorders.
Detailed description
Introduction: Temporomandibular disorders (TMD) are common symptoms in society, characterized by pain, limited movement, and all sounds, which are often negatively impacted by individual life circumstances. The primary goal of treatment is to eliminate the etiological factors and restore the replaceable functions of the parts. Arthrocentesis, a minimally invasive approach, is emphasized in cases where conservative treatment is beneficial. Arthrocentesis reduces pain by removing inflammatory mediators and increases joint mobility. This effective treatment was evaluated by comparing the intraoperative parameters and clinical success of different arthrocentesis techniques in patients with Wilkes stage 2-3 TMJ disorders.
Materials and Methods: This study is being conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Karadeniz Technical University. Fifty patients (Group 1: n=25, Group 2: n=25) treated with two different arthrocentesis technologies were enrolled retrospectively. The first group was the study of Mun et al. Arthrocentesis was performed using the method employed by Rahal et al., which consisted of two 22-gauge needles bent to form a "Y" shape and placed simultaneously and concentrically. The second group underwent arthrocentesis using a fabricated Y-shaped cannula used by Rahal et al. Each treatment was performed under local anesthesia, and the upper regions were irrigated with an average of 100 ml of Ringer's lactate solution. Following arthrocentesis, 1 ml of hyaluronic acid was injected into the patients. Preoperative and postoperative values were evaluated by comparing the groups at 1 to 6 months. Furthermore, intraoperative arthrocentesis efficiency (number of needle insertions, procedure time, complication rate, and treatment tolerance) was compared between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arthrocentesis was performed on the first group using a method developed by Mun et al., involving two 22-gauge needles bent to form a 'Y' shape with the tips facing each other, and on the second group using a factory-made Y-shaped cannula developed by Rahal et al.
| Arm | Type | Receives |
|---|---|---|
| Non-Welded Y-Cannula Group | Active comparator | Procedure: Y-shaped cannula without a sourceGroup 1: The first group underwent arthrocentesis using a method developed by Mun et al., involving two 22-gauge needles bent to form a Y-shape with their angles facing each other. |
| Welded Y-Cannula Group | Active comparator | Procedure: Y-shaped cannula with a sourceGroup 2: The second group underwent arthrocentesis using a method developed by Rahal et al., involving a factory-made Y-shaped cannula. |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Are in stages 2-3 of the Wilkes classification
- Have not undergone interventional treatment prior to arthroscopy
- Have undergone conservative treatment prior to arthroscopy without successful results
Key exclusion criteria (3 listed)
- Patients with TME irregularities who have undergone interventional treatment (minimally invasive and invasive)
- Patients with bilateral TME disorders
- Patients with incomplete recorded data
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 |
|---|---|---|
| Y-shaped cannula without a sourceY-shaped cannula without a source Arthrocentesis performed by simultaneously and concentrically placing two manually Y-shaped bent needles into the joint cavity. | Procedure or surgery | Non-Welded Y-Cannula Group |
| Y-shaped cannula with a sourceY-shaped cannula with a source Arthrocentesis performed by simultaneously and concentrically placing two manually Y-shaped bent needles into the joint cavity. | Procedure or surgery | Welded Y-Cannula Group |
Primary outcome
TMJ Pain
Time frame: before the procedure, at 1 month and at 6 months
TMJ Pain intensity was assessed using the Visual Analog Scale (VAS). The VAS ranges from a minimum score of 1 to a maximum score of 10, where 1 indicates the best condition (no pain) and 10 indicates the worst condition (maximum pain). Higher scores on the scale represent greater pain severity. Accordingly, an increase in the score reflects a higher level of perceived pain by the patients.
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 9 Apr 2026.
- 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.
- Individual participant dataSharing planned: No. It will be shared later if required for the confidentiality of the study.
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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 Y-shaped cannula without a source and Y-shaped cannula with a source in people with Temporomandibular Disorders (TMD) and Temporomandibular Joint Disc Displacement, With Reduction, run by Helin Merve Özalp 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 4 inclusion and 3 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 9 Apr 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?
TMJ Pain (time frame: before the procedure, at 1 month and at 6 months). 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 NCT07327099, which also lists 1 linked publication.
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 9 Apr 2026.