Temporomandibular Joint DisordersNCT06055855
Comparing Two-Needle vs. Surgery-Guided Arthrocentesis for TMJ Disorders
A study testing Traditional Two-Needle Arthrocentesis and Surgery-Guided Arthrocentesis in people with Temporomandibular Joint Disorders, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare two methods of arthrocentesis in treating temporomandibular joint (TMJ) disorders. The main questions it aims to answer are: Is surgery-guided arthrocentesis more efficient in terms of operation time compared to traditional two-needle arthrocentesis? Does the use of… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Traditional Two-Needle Arthrocentesis and Surgery-Guided Arthrocentesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2023to 10 Feb 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Wilkes stage II, III, or IV Temporomandibular Joint (TMJ) internal derangement.
- Presence of pain, sound, or both in the TMJ.
- Limitation or locking in mouth opening, or both.
- Patients who have not responded to symptoms after a minimum of three months of splint therapy.
Who cannot join
- Presence of infection in the puncture area.
- Presence of osteomyelitis in the neighboring region.
- Patients with uncontrolled coagulopathies.
- Patients experiencing limitation in maximum mouth opening without disk disorder.
- Patients with severe degenerative joint disease (e.g., deformed condylar contour, osteophyte findings in MRI).
- History of TMJ surgery.
- History of muscle-originated mandibular hypomobility.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Dentistry
Istanbul, 34854
About this study
Official title: A Randomized Controlled Trial Evaluating the Efficacy of Conventional Two-Needle Arthrocentesis Versus Surgery-Guided Arthrocentesis in the Management of Temporomandibular Joint Disorders
The goal of this clinical trial is to compare two methods of arthrocentesis in treating temporomandibular joint (TMJ) disorders. The main questions it aims to answer are:
Is surgery-guided arthrocentesis more efficient in terms of operation time compared to traditional two-needle arthrocentesis? Does the use of surgical guides lead to less postoperative pain and better patient comfort?
Read more
Participants will:
Undergo either the traditional two-needle arthrocentesis or the surgery-guided arthrocentesis.
Be monitored for operation time, postoperative pain, and overall patient comfort.
Researchers will compare the outcomes of patients who underwent traditional two-needle arthrocentesis with those who had surgery-guided arthrocentesis to see if the latter can shorten operation time and improve patient comfort.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Traditional Two-Needle Arthrocentesis, Surgery-Guided Arthrocentesis
- Keywords
- Arthrocentesis,Temporomandibular Joint, Guided surgery
- 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.
Traditional Two-Needle ArthrocentesisProcedure or surgery
Participants in this group will undergo arthrocentesis using the traditional two-needle technique. The procedure involves the placement of one or two needles into the temporomandibular joint (TMJ) to irrigate the joint space. Needle placement is guided by anatomical landmarks.
Surgery-Guided ArthrocentesisProcedure or surgery
Participants in this group will receive arthrocentesis facilitated by a surgical guide. The guide is generated through pre-operative planning and is designed to aid in the accurate placement of the needle into the TMJ.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Arthrocentesis Group | Active comparator | Not described Receives: Procedure: Traditional Two-Needle Arthrocentesis |
| Surgery-Guided Arthrocentesis Group | Experimental | Not described Receives: Procedure: Surgery-Guided Arthrocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Duration of Arthrocentesis Procedure
he primary outcome measure of the study is the total time duration required to complete the arthrocentesis procedure. This duration will be measured from the time local anesthesia is administered to the time when the arthrocentesis is completed. In addition, the number of intraoperative repositions of the needles will also be recorded.
Measured: Immediately following the completion of each arthrocentesis procedure, anticipated to occur on the day of the surgery.
Secondary outcomes (4)
Volume of Ringer's Solution Used for Joint Irrigation
The volume of Ringer's solution used to irrigate the temporomandibular joint during the arthrocentesis procedure will be measured.
Measured: Immediately following the completion of each arthrocentesis procedure, anticipated to occur on the day of the surgery.
Change in Postoperative Pain
Change in muscle pain intensity will be evaluated using a Visual Analogue Scale (VAS). The VAS comprises a 10 cm line, which can be presented either horizontally or vertically, anchored by "no pain" and "worst possible pain." Patients will be instructed to place a mark on the line that most accurately describes their level of muscle pain. These marks will be recorded and scored according to the VAS scale.
Measured: 7 days
Change in Mouth Opening
The distance between the mesio-incisal corners of the upper and lower central incisors was measured with the help of a ruler when the mouth opening was at its maximum.
Measured: 7 days
Change in Facial Swelling
With the technique described by Neupert ; Angle of mandible-tragus Angle of mandible-lateral canthus of eye Mandible corner-nose wing Angle of mandible oral-commissures Measurements were made with a tape measure from 5 points, with the mandible corner-pogonion.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start10 Sep 2023
- Primary completion10 Feb 2024
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferit Bayram, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055855
- Sponsor's protocol ID
- MUDHF_FB_007
- Status last verified
- Jul 2024
- First submitted
- 20 Sep 2023
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Efficacy of Conventional Two-Needle Arthrocentesis Versus Surgery-Guided Arthrocentesis in the Management of Temporomandibular Joint Disorders
- ClinicalTrials.gov ID
- NCT06055855
- Acronym / sponsor ID
- MUDHF_FB_007
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Arthrocentesis,Temporomandibular Joint, Guided surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 10 Feb 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 28 Sep 2023 (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 goal of this clinical trial is to compare two methods of arthrocentesis in treating temporomandibular joint (TMJ) disorders. The main questions it aims to answer are:
Is surgery-guided arthrocentesis more efficient in terms of operation time compared to traditional two-needle arthrocentesis? Does the use of surgical guides lead to less postoperative pain and better patient comfort?
Participants will:
Undergo either the traditional two-needle arthrocentesis or the surgery-guided arthrocentesis.
Be monitored for operation time, postoperative pain, and overall patient comfort.
Researchers will compare the outcomes of patients who underwent traditional two-needle arthrocentesis with those who had surgery-guided arthrocentesis to see if the latter can shorten operation time and improve patient comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Arthrocentesis Group | Active comparator | Procedure: Traditional Two-Needle Arthrocentesis |
| Surgery-Guided Arthrocentesis Group | Experimental | Procedure: Surgery-Guided Arthrocentesis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with Wilkes stage II, III, or IV Temporomandibular Joint (TMJ) internal derangement.
- Presence of pain, sound, or both in the TMJ.
- Limitation or locking in mouth opening, or both.
- Patients who have not responded to symptoms after a minimum of three months of splint therapy.
Key exclusion criteria (7 listed)
- Presence of infection in the puncture area.
- Presence of osteomyelitis in the neighboring region.
- Patients with uncontrolled coagulopathies.
- Patients experiencing limitation in maximum mouth opening without disk disorder.
- Patients with severe degenerative joint disease (e.g., deformed condylar contour, osteophyte findings in MRI).
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 |
|---|---|---|
| Traditional Two-Needle ArthrocentesisParticipants in this group will undergo arthrocentesis using the traditional two-needle technique. The procedure involves the placement of one or two needles into the temporomandibular joint (TMJ) to irrigate the joint space. Needle placement is guided by anatomical landmarks. | Procedure or surgery | Traditional Arthrocentesis Group |
| Surgery-Guided ArthrocentesisParticipants in this group will receive arthrocentesis facilitated by a surgical guide. The guide is generated through pre-operative planning and is designed to aid in the accurate placement of the needle into the TMJ. | Procedure or surgery | Surgery-Guided Arthrocentesis Group |
Primary outcome
Total Duration of Arthrocentesis Procedure
Time frame: Immediately following the completion of each arthrocentesis procedure, anticipated to occur on the day of the surgery.
he primary outcome measure of the study is the total time duration required to complete the arthrocentesis procedure. This duration will be measured from the time local anesthesia is administered to the time when the arthrocentesis is completed. In addition, the number of intraoperative repositions of the needles will also be recorded.
4 secondary outcomes
Volume of Ringer's Solution Used for Joint Irrigation
Time frame: Immediately following the completion of each arthrocentesis procedure, anticipated to occur on the day of the surgery.
Change in Postoperative Pain
Time frame: 7 days
Change in Mouth Opening
Time frame: 7 days
Change in Facial Swelling
Time frame: 7 days
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 12 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Temporomandibular Joint Disorders
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Recruiting
Clinical and Electromyographic Assessment of Occlusal Splint Therapy
Temporomandibular Joint Disorders
Recruiting
An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders
Temporomandibular Disorder, Orofacial Pain
Enrolling by invitationObservational study
Long-term Safety and Performance of Materialise's Patient-specific TMJ System.
Temporomandibular Joint Disorders
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 Traditional Two-Needle Arthrocentesis and Surgery-Guided Arthrocentesis in people with Temporomandibular Joint Disorders, run by Marmara 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 4 inclusion and 7 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 12 Jul 2024. 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?
Total Duration of Arthrocentesis Procedure (time frame: Immediately following the completion of each arthrocentesis procedure, anticipated to occur on the day of the surgery.). 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 12 Jul 2024.