TEMPOROMANDIBULAR JOINT DISORDERTMJ ARTHROCENTNCT07553078
EFFECT OF TMJ ARTHROCENTESIS ON ARTICULAR CAPSULAR WIDTH: AN ULTRASONOGRAPHIC STUDY
A study testing Arthrocentesis with ringer solution in people with TEMPOROMANDIBULAR JOINT DISORDER, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
This study is designed as a prospective cohort study evaluating the effect of temporomandibular joint arthrocentesis on articular capsular width using ultrasonography. The study is being conducted at the Faculty of Dentistry, Van Yuzuncu Yil University, Turkey, in accordance with the principles of the Declaration of… Read more about this study
- Who is it for?
- Ages 29 to 55 years
- Conditions the study is for
- TEMPOROMANDIBULAR JOINT DISORDER
- What is being tested?
- Arthrocentesis with ringer solution
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 1 Jan 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 29 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Systemically healthy adults with unilateral intra-articular TMD (disc displacement with or without reduction) for ≥6 months unresponsive to conservative treatment
Who cannot join
- Rheumatologic diseases, TMJ ankylosis, previous open TMJ surgery, pregnancy/breastfeeding, active infection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yuzuncu Yil University Dentistry Faculty
Van
About this study
Official title: TEMPOROMANDIBULAR JOINT ARTHROCENTESIS AND ITS EFFECT ON ARTICULAR CAPSULAR WIDTH: A CLINICAL ULTRASONOGRAPHIC STUDY
This study is designed as a prospective cohort study evaluating the effect of temporomandibular joint arthrocentesis on articular capsular width using ultrasonography. The study is being conducted at the Faculty of Dentistry, Van Yuzuncu Yil University, Turkey, in accordance with the principles of the Declaration of Helsinki. Ethical approval has been obtained from the Van Yuzuncu Yil University Clinical Research Ethics Committee (approval no. 2025/02-07, dated February 28, 2025).
The study includes systemically healthy adult participants with unilateral intra-articular temporomandibular disorder who have not responded adequately to at least six months of conservative management, including medication, occlusal splint therapy, or physiotherapy. Exclusion criteria are systemic rheumatologic diseases, bony or fibrous ankylosis of the temporomandibular joint, previous open temporomandibular joint surgery, pregnancy or breastfeeding, and active infection.
Read more
All participants undergo unilateral temporomandibular joint arthrocentesis performed under local anesthesia by a single experienced oral and maxillofacial surgeon. A standard two-needle technique is used, and the upper joint compartment is irrigated with 150-200 mL of sterile Ringer's lactate solution. No pharmacological agents are injected after the lavage. The contralateral, asymptomatic joint serves as an untreated control.
Ultrasonographic and clinical assessments are performed at three time points: baseline before the procedure (T0), three months post-arthrocentesis (T1), and six months post-arthrocentesis (T2). The primary outcome is capsular width measured by ultrasonography. Secondary outcomes include pain intensity assessed using the visual analog scale, maximum incisal opening measured in millimeters, and lateral and protrusive mandibular movements.
All ultrasonographic evaluations and clinical measurements are performed by a single oral and maxillofacial radiologist who is independent of the surgical procedure and postoperative patient management, ensuring blinding and minimizing bias. Pain scores are self-reported by patients without investigator interpretation.
The sample size was calculated a priori using G*Power software. Based on previous morphometric data, a minimum of 26 participants was required, and 27 participants were enrolled to account for potential dropouts. Statistical analyses include the Wilcoxon signed-rank test, Friedman test, and Mann-Whitney U test, with a significance level set at p < 0.05.
This study is one of the first prospective clinical trials to evaluate longitudinal changes in temporomandibular joint capsular width using ultrasonography following arthrocentesis. The study has received no external funding, and the authors declare no competing interests.
Read the detailed description
Temporomandibular joint (TMJ) arthrocentesis is a minimally invasive procedure used to treat intra-articular temporomandibular disorders (TMD) that are unresponsive to conservative management. This prospective cohort study aims to evaluate the effect of TMJ arthrocentesis on articular capsular width using ultrasonography, while concurrently assessing clinical outcomes including pain, maximum incisal opening, and mandibular movements.
The study is conducted at Van Yuzuncu Yil University Faculty of Dentistry, Turkey. Ethical approval was obtained from the Van Yuzuncu Yil University Non-Interventional Clinical Research Ethics Committee (approval no. 2025/02-07, dated February 28, 2025). The study adheres to the principles of the Declaration of Helsinki and follows TREND reporting guidelines for quasi-experimental studies.
All participants undergo unilateral TMJ arthrocentesis performed under local anesthesia using a standard two-needle technique. The upper joint compartment is irrigated with 150-200 mL of sterile Ringer's lactate solution. No pharmacological agents are injected after lavage. The contralateral asymptomatic joint serves as an untreated control.
Ultrasonographic and clinical assessments are performed at three time points: baseline (T0, pre-treatment), three months post-arthrocentesis (T1), and six months post-arthrocentesis (T2). All ultrasonographic evaluations are performed by a single oral and maxillofacial radiologist with 12 years of experience, using a high-resolution ultrasound device with a 14-16 MHz linear transducer. Capsular width is measured as the linear distance between the hyperechoic capsular line and the hyperechoic cortical outline of the mandibular condyle.
Clinical assessments include pain intensity measured by visual analog scale (VAS, 0-10), maximum incisal opening (MIO) in millimeters, lateral mandibular movements (left and right), and protrusive mandibular movement. All clinical measurements are performed by the same blinded assessor.
Statistical analyses are performed using SPSS software. The Friedman test is used for repeated measurements across three time points, followed by post-hoc pairwise comparisons using the Wilcoxon signed-rank test with Bonferroni correction. Between-group comparisons (affected vs. non-affected side) are performed using the Wilcoxon signed-rank test. A p-value of less than 0.05 is considered statistically significant.
Sample size was determined a priori using G*Power software. Based on previous morphometric data, a minimum of 26 participants was required. To account for potential dropouts, 27 participants were enrolled. A post-hoc power analysis based on the observed effect size for the primary outcome (Cohen's d = 1.42) confirmed >99% statistical power.
The study has received no external funding. The datasets are available from the corresponding author upon reasonable request.
- Conditions
- TEMPOROMANDIBULAR JOINT DISORDER
- Being tested
- Arthrocentesis with ringer solution
- Keywords
- TEMPORO MANDIBULAR JOINT, ARTHROCENTESIS, ULTRASONOGRAPHY
- 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.
Arthrocentesis with ringer solutionProcedure or surgery
TWO-NEEDLE TMJ ARTHROCENTESIS UNDER LOCAL ANESTHESIA. UPPER JOINT COMPARTMENT IRRIGATED WITH 150-200 ML STERILE RINGER'S LACTATE SOLUTION. NO PHARMACOLOGICAL AGENTS INJECTED AFTER LAVAGE.
| Study group | Role | What they receive |
|---|---|---|
| 1. Arm/Grup: Affected side (Arthrocentesis) | Experimental | Two-needle TMJ arthrocentesis under local anesthesia. Upper joint compartment irrigated with 150-200 mL sterile Ringer's lactate solution. No post-lavage injection. Receives: Procedure: Arthrocentesis with ringer solution |
| 2. Arm/Grup: Non-affected side (Control) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
TMJ CAPSULAR WIDTH
ULTRASONOGRAPHIC MEASUREMENT OF LINEAR DISTANCE BETWEEN HYPERECHOIC CAPSULAR LINE AND HYPERECHOIC CONDYLAR CORTEX IN MILLIMETERS.
Measured: MEASURED AT T0 (BASELINE), T1 (3 MONTHS), AND T2 (6 MONTHS) POST-ARTHROCENTESIS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start1 Mar 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
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 JOINT 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sema kaya, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553078
- Sponsor's protocol ID
- VANYYU_ARTHRO_01
- Acronym
- TMJ ARTHROCENT
- Status last verified
- Feb 2025
- First submitted
- 15 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATA MAY BE AVAILABLE FROM THE CORRESPONDING AUTHOR UPON REASONABLE REQUEST.
Publications
Sahar O, Kaya S. Temporomandibular joint arthrocentesis and its effect on articular capsular width: a clinical ultrasonographic study. BMC Oral Health. 2026 Jun 1. doi: 10.1186/s12903-026-08803-8. Online ahead of print.
PubMed 42226174
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEMPOROMANDIBULAR JOINT ARTHROCENTESIS AND ITS EFFECT ON ARTICULAR CAPSULAR WIDTH: A CLINICAL ULTRASONOGRAPHIC STUDY
- ClinicalTrials.gov ID
- NCT07553078
- Acronym / sponsor ID
- TMJ ARTHROCENT / VANYYU_ARTHRO_01
- Conditions
- TEMPOROMANDIBULAR JOINT DISORDER
- Keywords
- TEMPORO MANDIBULAR JOINT, ARTHROCENTESIS, ULTRASONOGRAPHY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 27 Apr 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.
This study is designed as a prospective cohort study evaluating the effect of temporomandibular joint arthrocentesis on articular capsular width using ultrasonography. The study is being conducted at the Faculty of Dentistry, Van Yuzuncu Yil University, Turkey, in accordance with the principles of the Declaration of Helsinki. Ethical approval has been obtained from the Van Yuzuncu Yil University Clinical Research Ethics Committee (approval no. 2025/02-07, dated February 28, 2025).
The study includes systemically healthy adult participants with unilateral intra-articular temporomandibular disorder who have not responded adequately to at least six months of conservative management, including medication, occlusal splint therapy, or physiotherapy. Exclusion criteria are systemic rheumatologic diseases, bony or fibrous ankylosis of the temporomandibular joint, previous open temporomandibular joint surgery, pregnancy or breastfeeding, and active infection.
All participants undergo unilateral temporomandibular joint arthrocentesis performed under local anesthesia by a single experienced oral and maxillofacial surgeon. A standard two-needle technique is used, and the upper joint compartment is irrigated with 150-200 mL of sterile Ringer's lactate solution. No pharmacological agents are injected after the lavage. The contralateral, asymptomatic joint serves as an untreated control.
Ultrasonographic and clinical assessments are performed at three time points: baseline before the procedure (T0), three months post-arthrocentesis (T1), and six months post-arthrocentesis (T2). The primary outcome is capsular width measured by ultrasonography. Secondary outcomes include pain intensity assessed using the visual analog scale, maximum incisal opening measured in millimeters, and lateral and protrusive mandibular movements.
All ultrasonographic evaluations and clinical measurements are performed by a single oral and maxillofacial radiologist who is independent of the surgical procedure and postoperative patient management, ensuring blinding and minimizing bias. Pain scores are self-reported by patients without investigator interpretation.
The sample size was calculated a priori using G*Power software. Based on previous morphometric data, a minimum of 26 participants was required, and 27 participants were enrolled to account for potential dropouts. Statistical analyses include the Wilcoxon signed-rank test, Friedman test, and Mann-Whitney U test, with a significance level set at p < 0.05.
This study is one of the first prospective clinical trials to evaluate longitudinal changes in temporomandibular joint capsular width using ultrasonography following arthrocentesis. The study has received no external funding, and the authors declare no competing interests.
Detailed description
Temporomandibular joint (TMJ) arthrocentesis is a minimally invasive procedure used to treat intra-articular temporomandibular disorders (TMD) that are unresponsive to conservative management. This prospective cohort study aims to evaluate the effect of TMJ arthrocentesis on articular capsular width using ultrasonography, while concurrently assessing clinical outcomes including pain, maximum incisal opening, and mandibular movements.
The study is conducted at Van Yuzuncu Yil University Faculty of Dentistry, Turkey. Ethical approval was obtained from the Van Yuzuncu Yil University Non-Interventional Clinical Research Ethics Committee (approval no. 2025/02-07, dated February 28, 2025). The study adheres to the principles of the Declaration of Helsinki and follows TREND reporting guidelines for quasi-experimental studies.
All participants undergo unilateral TMJ arthrocentesis performed under local anesthesia using a standard two-needle technique. The upper joint compartment is irrigated with 150-200 mL of sterile Ringer's lactate solution. No pharmacological agents are injected after lavage. The contralateral asymptomatic joint serves as an untreated control.
Ultrasonographic and clinical assessments are performed at three time points: baseline (T0, pre-treatment), three months post-arthrocentesis (T1), and six months post-arthrocentesis (T2). All ultrasonographic evaluations are performed by a single oral and maxillofacial radiologist with 12 years of experience, using a high-resolution ultrasound device with a 14-16 MHz linear transducer. Capsular width is measured as the linear distance between the hyperechoic capsular line and the hyperechoic cortical outline of the mandibular condyle.
Clinical assessments include pain intensity measured by visual analog scale (VAS, 0-10), maximum incisal opening (MIO) in millimeters, lateral mandibular movements (left and right), and protrusive mandibular movement. All clinical measurements are performed by the same blinded assessor.
Statistical analyses are performed using SPSS software. The Friedman test is used for repeated measurements across three time points, followed by post-hoc pairwise comparisons using the Wilcoxon signed-rank test with Bonferroni correction. Between-group comparisons (affected vs. non-affected side) are performed using the Wilcoxon signed-rank test. A p-value of less than 0.05 is considered statistically significant.
Sample size was determined a priori using G*Power software. Based on previous morphometric data, a minimum of 26 participants was required. To account for potential dropouts, 27 participants were enrolled. A post-hoc power analysis based on the observed effect size for the primary outcome (Cohen's d = 1.42) confirmed >99% statistical power.
The study has received no external funding. The datasets are available from the corresponding author upon reasonable request.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Arm/Grup: Affected side (Arthrocentesis) | Experimental | Procedure: Arthrocentesis with ringer solutionTwo-needle TMJ arthrocentesis under local anesthesia. Upper joint compartment irrigated with 150-200 mL sterile Ringer's lactate solution. No post-lavage injection. |
| 2. Arm/Grup: Non-affected side (Control) | No intervention | – |
Who may qualify
- Ages
- 29 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Systemically healthy adults with unilateral intra-articular TMD (disc displacement with or without reduction) for ≥6 months unresponsive to conservative treatment
Key exclusion criteria (1 listed)
- Rheumatologic diseases, TMJ ankylosis, previous open TMJ surgery, pregnancy/breastfeeding, active infection
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 |
|---|---|---|
| Arthrocentesis with ringer solutionTWO-NEEDLE TMJ ARTHROCENTESIS UNDER LOCAL ANESTHESIA. UPPER JOINT COMPARTMENT IRRIGATED WITH 150-200 ML STERILE RINGER'S LACTATE SOLUTION. NO PHARMACOLOGICAL AGENTS INJECTED AFTER LAVAGE. | Procedure or surgery | 1. Arm/Grup: Affected side (Arthrocentesis) |
Primary outcome
TMJ CAPSULAR WIDTH
Time frame: MEASURED AT T0 (BASELINE), T1 (3 MONTHS), AND T2 (6 MONTHS) POST-ARTHROCENTESIS.
ULTRASONOGRAPHIC MEASUREMENT OF LINEAR DISTANCE BETWEEN HYPERECHOIC CAPSULAR LINE AND HYPERECHOIC CONDYLAR CORTEX IN MILLIMETERS.
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 27 Apr 2026.
- Derived from this study: PubMed 42226174Sahar O, Kaya S. Temporomandibular joint arthrocentesis and its effect on articular capsular width: a clinical ultrasonographic study. BMC Oral Health. 2026 Jun 1. doi: 10.1186/s12903-026-08803-8. Online ahead of print.
- Individual participant dataSharing planned: No. DATA MAY BE AVAILABLE FROM THE CORRESPONDING AUTHOR UPON REASONABLE REQUEST.
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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 Arthrocentesis with ringer solution in people with TEMPOROMANDIBULAR JOINT DISORDER, run by Yuzuncu Yil 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 1 inclusion and 1 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 27 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 CAPSULAR WIDTH (time frame: MEASURED AT T0 (BASELINE), T1 (3 MONTHS), AND T2 (6 MONTHS) POST-ARTHROCENTESIS.). 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 NCT07553078, 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 27 Apr 2026.