TMJ Disc DisorderNCT06757322
Comparing Single Needle and Double Needle Arthrocentesis for Temporomandibular Joint Disorders
A study testing Singel Needle Double Cannula TMJ Arthrocentesis and Double Needle TMJ Arthrocentesis in people with TMJ Disc Disorder, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to compare the clinical success and efficacy of single-needle, double-cannula arthrocentesis with conventional arthrocentesis techniques in patients with temporomandibular joint disorders. Patients with nonreducible disc displacement complained of limited mouth opening and/or pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TMJ Disc Disorder
- What is being tested?
- Singel Needle Double Cannula TMJ Arthrocentesis and Double Needle TMJ Arthrocentesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 30 Oct 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- with complaints of pain and restricted mouth opening and who had not received any previous treatment.
- Patients with a diagnosis of disc displacement without reduction characterized by persistent or frequent TMJ pain, history of joint clicking, limited mouth opening with deviation to the affected side, limited lateral movement to the opposite side, limited protrusive movements with deviation to the affected side were included.
Who cannot join
- Patients with systemic inflammatory joint disease, facial growth disorder, and direct trauma to the TMJ were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yüzüncü Yıl Üniversitesi Diş Hekimliği Fakültesi
Van, 65080
About this study
Official title: Comparison of Single Needle-Double Cannula and Double Needle Arthrocentesis in Temporomandibular Joint Disorders
The purpose of this study was to compare the clinical success and efficacy of single-needle, double-cannula arthrocentesis with conventional arthrocentesis techniques in patients with temporomandibular joint disorders. Patients with nonreducible disc displacement complained of limited mouth opening and/or pain. All treated patients had baseline and follow-up (with mouth opening and VAS). Comparisons were made within and between groups.
Read the detailed description
The patients included in the study were evaluated in the preoperative, 1week, 1-3, and 6 months after the procedure. Double-needle group: two needles were inserted into the joint and washed. In the single-needle group, two needles were bent (from their lower parts) before the procedure and their pointed ends were joined by placing acrylic on the plastic parts from a single point. The resulting combined needle was directed to the upper joint space and washed. 13 underwent single-needle double cannula arthrocentesis and 15 underwent double needle arthrocentesis.
- Conditions
- TMJ Disc Disorder
- Being tested
- Singel Needle Double Cannula TMJ Arthrocentesis, Double Needle TMJ Arthrocentesis
- Keywords
- arthrocentesis, disc displacement without reduction, temporomandibular joint disorders
- 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.
Singel Needle Double Cannula TMJ ArthrocentesisProcedure or surgery
Artocentesis describes the lavage of the TMJ by introducing a saline/ringer lactate solution through a needle inserted into the upper joint cavity. TMJ arthrocentesis was first introduced as a double needle entry method by Nitzan et al in 1991. The single needle technique was developed by Singh and Varghese and introduced in 2013. The single needle method is a more simplified modification of the first method.
Double Needle TMJ ArthrocentesisProcedure or surgery
Artocentesis describes the lavage of the TMJ by introducing a saline/ringer lactate solution through a needle inserted into the upper joint cavity. TMJ arthrocentesis was first introduced as a double needle entry method by Nitzan et al in 1991.
| Study group | Role | What they receive |
|---|---|---|
| single-needle double cannula arthrocentesis group | Active comparator | In the single-needle group, two needles were bent (from their lower parts) before the procedure and their pointed ends were joined by placing acrylic on the plastic parts from a single point. The resulting combined needle was directed to the upper joint space and washed. Receives: Procedure: Singel Needle Double Cannula TMJ Arthrocentesis |
| Double-needle arthrocentesis group | Active comparator | Two needles were inserted into the TMJ and washed. Receives: Procedure: Double Needle TMJ Arthrocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in mouth opening
The maximum mouth opening of the patients was noted in centimeters before arthrocentesis and in the control sessions, and the changes between the sessions were compared.
Measured: Until the 6th month after TMJ Arthrocentesis
VAS Pain Scor
The VAS pain assessments of the patients before and during the arthrocentesis and control sessions were noted and changes between sessions were compared. The VAS score is an assessment in which we note the patient's pain assessment between 0 and 10. '0' means no pain, while '10' means the worst possible pain. As the number increases, it indicates that the patient's pain increases.
Measured: Until the 6th month after TMJ Arthrocentesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Jan 2022
- Primary completion1 Mar 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Keskin Tunc, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757322
- Sponsor's protocol ID
- YYU/06/04.03.2020
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Senturk MF, Cambazoglu M. A new classification for temporomandibular joint arthrocentesis techniques. Int J Oral Maxillofac Surg. 2015 Mar;44(3):417-8. doi: 10.1016/j.ijom.2014.11.014. Epub 2014 Dec 17. No abstract available.
PubMed 25529932Sequeira J, Rao BHS, Kedia PR. Efficacy of Sodium Hyaluronate for Temporomandibular Joint Disorder by Single-Puncture Arthrocentesis. J Maxillofac Oral Surg. 2019 Mar;18(1):88-92. doi: 10.1007/s12663-018-1093-4. Epub 2018 Feb 27.
PubMed 30728698Nagori SA, Jose A, Roychoudhury A. Comparison of intraoperative outcomes with single and double puncture techniques of arthrocentesis of the temporomandibular joint. Br J Oral Maxillofac Surg. 2020 Oct;58(8):928-932. doi: 10.1016/j.bjoms.2020.04.011. Epub 2020 Jul 16.
PubMed 32684314Folle FS, Poluha RL, Setogutti ET, Grossmann E. Double puncture versus single puncture arthrocentesis for the management of unilateral temporomandibular joint disc displacement without reduction: A randomized controlled trial. J Craniomaxillofac Surg. 2018 Dec;46(12):2003-2007. doi: 10.1016/j.jcms.2018.10.015. Epub 2018 Oct 26.
PubMed 30446325Nagori SA, Bansal A, Jose A, Roychoudhury A. Comparison of outcomes with the single-puncture and double-puncture techniques of arthrocentesis of the temporomandibular joint: An updated systematic review and meta-analysis. J Oral Rehabil. 2021 Sep;48(9):1056-1065. doi: 10.1111/joor.13228. Epub 2021 Jul 23.
PubMed 34273184Senturk MF, Tuzuner-Oncul AM, Cambazoglu M. Prospective short term comparison of outcomes after single or double puncture arthrocentesis of the temporomandibular joint. Br J Oral Maxillofac Surg. 2016 Jan;54(1):26-9. doi: 10.1016/j.bjoms.2015.11.004. Epub 2015 Nov 30.
PubMed 26782027Bayramoglu Z, Tozoglu S. Comparison of single- and double-puncture arthrocentesis for the treatment of temporomandibular joint disorders: A six-month, prospective study. Cranio. 2021 Mar;39(2):151-156. doi: 10.1080/08869634.2019.1603796. Epub 2019 Apr 25.
PubMed 31021311Talaat W, Ghoneim MM, Elsholkamy M. Single-needle arthrocentesis (Shepard cannula) vs. double-needle arthrocentesis for treating disc displacement without reduction. Cranio. 2016 Sep;34(5):296-302. doi: 10.1080/08869634.2015.1106810. Epub 2016 Apr 13.
PubMed 27077267Senturk 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 28618972Siewert-Gutowska M, Pokrowiecki R, Kaminski A, Zawadzki P, Stopa Z. State of the Art in Temporomandibular Joint Arthrocentesis-A Systematic Review. J Clin Med. 2023 Jun 30;12(13):4439. doi: 10.3390/jcm12134439.
PubMed 37445474Alkan A, Bas B. The use of double-needle canula method for temporomandibular joint arthrocentesis: clinical report. Eur J Dent. 2007 Jul;1(3):179-82.
PubMed 19212563Tvrdy P, Heinz P, Pink R. Arthrocentesis of the temporomandibular joint: a review. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2015 Mar;159(1):31-4. doi: 10.5507/bp.2013.026. Epub 2013 Apr 10.
PubMed 23579112
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Single Needle-Double Cannula and Double Needle Arthrocentesis in Temporomandibular Joint Disorders
- ClinicalTrials.gov ID
- NCT06757322
- Acronym / sponsor ID
- YYU/06/04.03.2020
- Conditions
- TMJ Disc Disorder
- Keywords
- arthrocentesis, disc displacement without reduction, temporomandibular joint disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 3 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 purpose of this study was to compare the clinical success and efficacy of single-needle, double-cannula arthrocentesis with conventional arthrocentesis techniques in patients with temporomandibular joint disorders. Patients with nonreducible disc displacement complained of limited mouth opening and/or pain. All treated patients had baseline and follow-up (with mouth opening and VAS). Comparisons were made within and between groups.
Detailed description
The patients included in the study were evaluated in the preoperative, 1week, 1-3, and 6 months after the procedure. Double-needle group: two needles were inserted into the joint and washed. In the single-needle group, two needles were bent (from their lower parts) before the procedure and their pointed ends were joined by placing acrylic on the plastic parts from a single point. The resulting combined needle was directed to the upper joint space and washed. 13 underwent single-needle double cannula arthrocentesis and 15 underwent double needle arthrocentesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single-needle double cannula arthrocentesis group | Active comparator | Procedure: Singel Needle Double Cannula TMJ ArthrocentesisIn the single-needle group, two needles were bent (from their lower parts) before the procedure and their pointed ends were joined by placing acrylic on the plastic parts from a single point. The resulting combined needle was directed to the upper joint space and washed. |
| Double-needle arthrocentesis group | Active comparator | Procedure: Double Needle TMJ ArthrocentesisTwo needles were inserted into the TMJ and washed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- with complaints of pain and restricted mouth opening and who had not received any previous treatment.
- Patients with a diagnosis of disc displacement without reduction characterized by persistent or frequent TMJ pain, history of joint clicking, limited mouth opening with deviation to the affected side, limited lateral movement to the opposite side, limited protrusive movements with deviation to the affected side were included.
Key exclusion criteria (1 listed)
- Patients with systemic inflammatory joint disease, facial growth disorder, and direct trauma to the TMJ were excluded.
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 |
|---|---|---|
| Singel Needle Double Cannula TMJ ArthrocentesisArtocentesis describes the lavage of the TMJ by introducing a saline/ringer lactate solution through a needle inserted into the upper joint cavity. TMJ arthrocentesis was first introduced as a double needle entry method by Nitzan et al in 1991. The single needle technique was developed by Singh and Varghese and introduced in 2013. The single needle method is a more simplified modification of the first method. | Procedure or surgery | single-needle double cannula arthrocentesis group |
| Double Needle TMJ ArthrocentesisArtocentesis describes the lavage of the TMJ by introducing a saline/ringer lactate solution through a needle inserted into the upper joint cavity. TMJ arthrocentesis was first introduced as a double needle entry method by Nitzan et al in 1991. | Procedure or surgery | Double-needle arthrocentesis group |
Primary outcome
change in mouth opening
Time frame: Until the 6th month after TMJ Arthrocentesis
The maximum mouth opening of the patients was noted in centimeters before arthrocentesis and in the control sessions, and the changes between the sessions were compared.
VAS Pain Scor
Time frame: Until the 6th month after TMJ Arthrocentesis
The VAS pain assessments of the patients before and during the arthrocentesis and control sessions were noted and changes between sessions were compared. The VAS score is an assessment in which we note the patient's pain assessment between 0 and 10. '0' means no pain, while '10' means the worst possible pain. As the number increases, it indicates that the patient's pain increases.
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 3 Jan 2025.
- Background: PubMed 25529932Senturk MF, Cambazoglu M. A new classification for temporomandibular joint arthrocentesis techniques. Int J Oral Maxillofac Surg. 2015 Mar;44(3):417-8. doi: 10.1016/j.ijom.2014.11.014. Epub 2014 Dec 17. No abstract available.
- Background: PubMed 30728698Sequeira J, Rao BHS, Kedia PR. Efficacy of Sodium Hyaluronate for Temporomandibular Joint Disorder by Single-Puncture Arthrocentesis. J Maxillofac Oral Surg. 2019 Mar;18(1):88-92. doi: 10.1007/s12663-018-1093-4. Epub 2018 Feb 27.
- Background: PubMed 32684314Nagori SA, Jose A, Roychoudhury A. Comparison of intraoperative outcomes with single and double puncture techniques of arthrocentesis of the temporomandibular joint. Br J Oral Maxillofac Surg. 2020 Oct;58(8):928-932. doi: 10.1016/j.bjoms.2020.04.011. Epub 2020 Jul 16.
- Background: PubMed 30446325Folle FS, Poluha RL, Setogutti ET, Grossmann E. Double puncture versus single puncture arthrocentesis for the management of unilateral temporomandibular joint disc displacement without reduction: A randomized controlled trial. J Craniomaxillofac Surg. 2018 Dec;46(12):2003-2007. doi: 10.1016/j.jcms.2018.10.015. Epub 2018 Oct 26.
- Background: PubMed 34273184Nagori SA, Bansal A, Jose A, Roychoudhury A. Comparison of outcomes with the single-puncture and double-puncture techniques of arthrocentesis of the temporomandibular joint: An updated systematic review and meta-analysis. J Oral Rehabil. 2021 Sep;48(9):1056-1065. doi: 10.1111/joor.13228. Epub 2021 Jul 23.
- Background: PubMed 26782027Senturk MF, Tuzuner-Oncul AM, Cambazoglu M. Prospective short term comparison of outcomes after single or double puncture arthrocentesis of the temporomandibular joint. Br J Oral Maxillofac Surg. 2016 Jan;54(1):26-9. doi: 10.1016/j.bjoms.2015.11.004. Epub 2015 Nov 30.
- Background: PubMed 31021311Bayramoglu Z, Tozoglu S. Comparison of single- and double-puncture arthrocentesis for the treatment of temporomandibular joint disorders: A six-month, prospective study. Cranio. 2021 Mar;39(2):151-156. doi: 10.1080/08869634.2019.1603796. Epub 2019 Apr 25.
- Background: PubMed 27077267Talaat W, Ghoneim MM, Elsholkamy M. Single-needle arthrocentesis (Shepard cannula) vs. double-needle arthrocentesis for treating disc displacement without reduction. Cranio. 2016 Sep;34(5):296-302. doi: 10.1080/08869634.2015.1106810. Epub 2016 Apr 13.
- Background: 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.
- Background: PubMed 37445474Siewert-Gutowska M, Pokrowiecki R, Kaminski A, Zawadzki P, Stopa Z. State of the Art in Temporomandibular Joint Arthrocentesis-A Systematic Review. J Clin Med. 2023 Jun 30;12(13):4439. doi: 10.3390/jcm12134439.
- Background: PubMed 19212563Alkan A, Bas B. The use of double-needle canula method for temporomandibular joint arthrocentesis: clinical report. Eur J Dent. 2007 Jul;1(3):179-82.
- Background: PubMed 23579112Tvrdy P, Heinz P, Pink R. Arthrocentesis of the temporomandibular joint: a review. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2015 Mar;159(1):31-4. doi: 10.5507/bp.2013.026. Epub 2013 Apr 10.
- Individual participant dataSharing planned: No
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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 Singel Needle Double Cannula TMJ Arthrocentesis and Double Needle TMJ Arthrocentesis in people with TMJ Disc 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 2 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 3 Jan 2025. 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 mouth opening (time frame: Until the 6th month after TMJ Arthrocentesis). 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 NCT06757322, which also lists 12 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 3 Jan 2025.