Temporomandibular Joint DisordersNCT05671549
Combined Arthrocentesis and Occlusal Splint Therapy for Closed Locks of the TMJ
A study testing Arthrocentesis of the temporomandibular joint in people with Temporomandibular Joint Disorders, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this prospective cohort study is to evaluate the effectiveness of combined arthrocentesis and occlusal stabilization splint therapy in patients diagnosed with disc displacement without reduction of temporomandibular joint-induced closed locks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Arthrocentesis of the temporomandibular joint
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 May 2019to 10 Jun 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals over the age of 18
- completion of the arthrocentesis treatment without any complications;
- the presence of preoperative information and postoperative follow-up data;
- persistent complaints despite conservative methods (behavioral modification, diet restrictions, non-steroid anti-inflammatory drugs, and physical therapy) for at least three months.
Who cannot join
- diagnosed with any connective tissue, neurological, dermatological, inflammatory diseases, and TMD other than DDWoR,
- who underwent TMJ surgeries, arthrocentesis procedures, TMJ ankylosis surgery,
- previously used occlusal splints,
- who developed complications in the application of arthrocentesis in the current study (low-volume lavage, extravasation, inability to reach the upper joint space, e.g.),
- with lack of teeth to affect the fabrication of the occlusal stabilization splint,
- with a history of radiotherapy of the head and neck.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University, Faculty of Dentistry
Tokat Province, 60100
About this study
Official title: Evaluation of the Effects of Arthrocentesis Combined With Occlusal Stabilization Splint on Disc Displacement Without Reduction-induced Acute and Closed Lock. A Prospective Cohort Study
The goal of this prospective cohort study is to evaluate the effectiveness of combined arthrocentesis and occlusal stabilization splint therapy in patients diagnosed with disc displacement without reduction of temporomandibular joint-induced closed locks. The main questions it aims to answer are:
- Is there a difference in the treatment response between chronic and acute closed-lock conditions?
- On which dimensions of pain did the treatment have positive effects? Participants will be preoperatively examined and assigned to one of the two study groups.
- All participants undergo a single session of TMJ arthrocentesis.
- Following the arthrocentesis session, all participants will use preoperatively fabricated occlusal splints.
- Participants will be recalled in one week to evaluate the outcomes. Researchers will compare acute and chronic closed-lock groups to see if there are differences between pain intensities and mouth-opening amounts postoperatively.
Read the detailed description
The study sample constituted patients diagnosed with DDWoR with limited opening according to the Turkish version of the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD Axis 1 questionnaire and examination form). The included patients with DDWoR-induced complaints persisting for more than three months were considered chronic (Group 1), and those with a shorter duration were considered acute (Group 2). For clinical diagnosis of DDWoR, Significant limitation of mouth opening, less than 35 mm assisted mouth opening, less than 4 mm increase in mouth opening with passive stretching, less than 7 mm contralateral movement of the mandible, and deviation of the mandible to the affected side during mouth opening was considered sufficient. The DC/TMD questionnaire and clinical examination diagnoses were confirmed by magnetic resonance images (MRI).
Preoperative and postoperative clinical examinations consisted of recording demographic information, amount of maximum mouth opening (MMO), and determination of McGill Pain Questionnaire (MPQ) and Visual Analog Scale (VAS) scores. MMO values were determined as the distance between the incisal edges of upper and lower central teeth and recorded in millimeters. MPQ scores were obtained with the questionnaire form consisting of four subsections. In the first subsection of the questionnaire, besides the patient's demographic data, the location of the current pain and whether it comes from superficial or deep tissues are questioned. In the second subsection, there are 20-word groups containing 78 words that ask the Sensory (groups 1-10), Affective (groups 11-15), Evaluative (group 16), and Miscellaneous (groups 17-20) components of current pain. In the third subsection, the relationship of pain with time is questioned. There are word groups to determine the continuity of pain, its frequency, and factors that increase or reduce pain. In the fourth subsection, five-word groups ranging from "mild" pain to "unbearable" pain to determine the severity of the pain; There are also six questions to assess the severity of pain that the patient can accept or experience without discomfort, which is also defined as "experienceable=target pain." The obtainable MPQ scores range from 0 to 78. The higher the scores, the greater the pain. Also, preoperative and postoperative VAS scores were obtained by marking a point on a 10 cm line. The score was calculated as the distance in centimeters between the zero and the marked points.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Arthrocentesis of the temporomandibular joint
- Keywords
- Arthrocentesis, Closed lock, Stabilization splint
- 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 of the temporomandibular jointProcedure or surgery
Arthrocentesis of the temporomandibular joint is a minimally invasive method performed under local anesthesia to irrigate the upper temporomandibular joint cavity with biocompatible substances. The procedure aims to wash out intra-articular inflammatory substances, reduce pain and restore the function of the related joint.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Closed-Lock | Active comparator | The participants will be enrolled in this group regarding the duration (longer than three months) of their symptoms. The allocated participants will undergo one session of the arthrocentesis procedure. The prefabricated occlusal stabilization splints will be applied. The participants' preoperative, postoperative immediate, and postoperative seventh-day pain intensities and maximum mouth-opening amounts will be recorded and analyzed. Receives: Procedure: Arthrocentesis of the temporomandibular joint |
| Acute Closed-Lock | Active comparator | The participants will be enrolled in this group regarding the duration (shorter than three months) of their symptoms. The allocated participants will undergo one session of the arthrocentesis procedure. The prefabricated occlusal stabilization splints will be applied. The participants' preoperative, postoperative immediate, and postoperative seventh-day pain intensities and maximum mouth-opening amounts will be recorded and analyzed. Receives: Procedure: Arthrocentesis of the temporomandibular joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Pain intensity with Visual analog scale
The pain intensity measurement was performed with the Visual analog scale (VAS), in which 0 referred to 'no pain,' 5 referred to 'moderate pain,' and ten referred to 'excruciating pain.' The patients were asked to mark their pain intensities on the VAS scale.
Measured: At the initial visit before arthrocentesis procedure.
Baseline Pain intensity with McGill pain questionnaire
The pain intensity measurement was performed with the McGill Pain Questionnaire form. According to the word groups chosen by the participants, the total score of the questionnaire varies between 0-78. An increase in the total score is interpreted as the severity of pain intensity.
Measured: At the initial visit before arthrocentesis procedure.
Change From Baseline Maximum Mouth Opening on Postoperative Follow Up Visits
All patients' maximal mouth opening were measured and recorded as the distance between upper and lower right central incisors.
Measured: At the initial visit, at the session of arthrocentesis postoperatively, at the first week
Postoperative Pain intensity with Visual analog scale
The pain intensity measurement was performed with the Visual analog scale (VAS), in which 0 referred to 'no pain,' 5 referred to 'moderate pain,' and ten referred to 'excruciating pain.' The patients were asked to mark their pain intensities on the VAS scale.
Measured: At first week follow-up visit
Postoperative Pain intensity with McGill pain questionnaire
The pain intensity measurements were performed with the McGill Pain Questionnaire form. According to the word groups chosen by the participants, the total score of the questionnaire varies between 0-78. An increase in the total score is interpreted as the severity of pain intensity.
Measured: At first week follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start29 May 2019
- Primary completion25 Aug 2021
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aras Erdil, Tokat Gaziosmanpasa University
- Investigators
- Mehmet K. Tümer, AssocProfDr, Study director, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671549
- Sponsor's protocol ID
- 83116987-381
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2023
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data regarding participants were made available in the manuscript
Publications
Hosgor H. Is arthrocentesis plus hyaluronic acid superior to arthrocentesis alone in the treatment of disc displacement without reduction in patients with bruxism? J Craniomaxillofac Surg. 2020 Nov;48(11):1023-1027. doi: 10.1016/j.jcms.2020.07.008. Epub 2020 Jul 25.
PubMed 33028488Tatli U, Benlidayi ME, Ekren O, Salimov F. Comparison of the effectiveness of three different treatment methods for temporomandibular joint disc displacement without reduction. Int J Oral Maxillofac Surg. 2017 May;46(5):603-609. doi: 10.1016/j.ijom.2017.01.018. Epub 2017 Feb 20.
PubMed 28222947Erdil A, Demirsoy MS, Tumer MK. Evaluation of the effects of arthrocentesis combined with occlusal stabilization splint on disc displacement without reduction-induced acute and closed lock. A prospective cohort study. J Stomatol Oral Maxillofac Surg. 2023 Oct;124(5):101438. doi: 10.1016/j.jormas.2023.101438. Epub 2023 Mar 12.
PubMed 36918123
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Arthrocentesis Combined With Occlusal Stabilization Splint on Disc Displacement Without Reduction-induced Acute and Closed Lock. A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05671549
- Acronym / sponsor ID
- 83116987-381
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Arthrocentesis, Closed lock, Stabilization splint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 29 May 2019 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 4 Jan 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 prospective cohort study is to evaluate the effectiveness of combined arthrocentesis and occlusal stabilization splint therapy in patients diagnosed with disc displacement without reduction of temporomandibular joint-induced closed locks. The main questions it aims to answer are:
- Is there a difference in the treatment response between chronic and acute closed-lock conditions?
- On which dimensions of pain did the treatment have positive effects? Participants will be preoperatively examined and assigned to one of the two study groups.
- All participants undergo a single session of TMJ arthrocentesis.
- Following the arthrocentesis session, all participants will use preoperatively fabricated occlusal splints.
- Participants will be recalled in one week to evaluate the outcomes. Researchers will compare acute and chronic closed-lock groups to see if there are differences between pain intensities and mouth-opening amounts postoperatively.
Detailed description
The study sample constituted patients diagnosed with DDWoR with limited opening according to the Turkish version of the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD Axis 1 questionnaire and examination form). The included patients with DDWoR-induced complaints persisting for more than three months were considered chronic (Group 1), and those with a shorter duration were considered acute (Group 2). For clinical diagnosis of DDWoR, Significant limitation of mouth opening, less than 35 mm assisted mouth opening, less than 4 mm increase in mouth opening with passive stretching, less than 7 mm contralateral movement of the mandible, and deviation of the mandible to the affected side during mouth opening was considered sufficient. The DC/TMD questionnaire and clinical examination diagnoses were confirmed by magnetic resonance images (MRI).
Preoperative and postoperative clinical examinations consisted of recording demographic information, amount of maximum mouth opening (MMO), and determination of McGill Pain Questionnaire (MPQ) and Visual Analog Scale (VAS) scores. MMO values were determined as the distance between the incisal edges of upper and lower central teeth and recorded in millimeters. MPQ scores were obtained with the questionnaire form consisting of four subsections. In the first subsection of the questionnaire, besides the patient's demographic data, the location of the current pain and whether it comes from superficial or deep tissues are questioned. In the second subsection, there are 20-word groups containing 78 words that ask the Sensory (groups 1-10), Affective (groups 11-15), Evaluative (group 16), and Miscellaneous (groups 17-20) components of current pain. In the third subsection, the relationship of pain with time is questioned. There are word groups to determine the continuity of pain, its frequency, and factors that increase or reduce pain. In the fourth subsection, five-word groups ranging from "mild" pain to "unbearable" pain to determine the severity of the pain; There are also six questions to assess the severity of pain that the patient can accept or experience without discomfort, which is also defined as "experienceable=target pain." The obtainable MPQ scores range from 0 to 78. The higher the scores, the greater the pain. Also, preoperative and postoperative VAS scores were obtained by marking a point on a 10 cm line. The score was calculated as the distance in centimeters between the zero and the marked points.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Closed-Lock | Active comparator | Procedure: Arthrocentesis of the temporomandibular jointThe participants will be enrolled in this group regarding the duration (longer than three months) of their symptoms. The allocated participants will undergo one session of the arthrocentesis procedure. The prefabricated occlusal stabilization splints will be applied. The participants' preoperative, postoperative immediate, and postoperative seventh-day pain intensities and maximum mouth-opening amounts will be recorded and analyzed. |
| Acute Closed-Lock | Active comparator | Procedure: Arthrocentesis of the temporomandibular jointThe participants will be enrolled in this group regarding the duration (shorter than three months) of their symptoms. The allocated participants will undergo one session of the arthrocentesis procedure. The prefabricated occlusal stabilization splints will be applied. The participants' preoperative, postoperative immediate, and postoperative seventh-day pain intensities and maximum mouth-opening amounts will be recorded and analyzed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- individuals over the age of 18
- completion of the arthrocentesis treatment without any complications;
- the presence of preoperative information and postoperative follow-up data;
- persistent complaints despite conservative methods (behavioral modification, diet restrictions, non-steroid anti-inflammatory drugs, and physical therapy) for at least three months.
Key exclusion criteria (6 listed)
- diagnosed with any connective tissue, neurological, dermatological, inflammatory diseases, and TMD other than DDWoR,
- who underwent TMJ surgeries, arthrocentesis procedures, TMJ ankylosis surgery,
- previously used occlusal splints,
- who developed complications in the application of arthrocentesis in the current study (low-volume lavage, extravasation, inability to reach the upper joint space, e.g.),
- with lack of teeth to affect the fabrication of the occlusal stabilization splint,
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 of the temporomandibular jointArthrocentesis of the temporomandibular joint is a minimally invasive method performed under local anesthesia to irrigate the upper temporomandibular joint cavity with biocompatible substances. The procedure aims to wash out intra-articular inflammatory substances, reduce pain and restore the function of the related joint. | Procedure or surgery | Acute Closed-Lock, Chronic Closed-Lock |
Primary outcome
Baseline Pain intensity with Visual analog scale
Time frame: At the initial visit before arthrocentesis procedure.
The pain intensity measurement was performed with the Visual analog scale (VAS), in which 0 referred to 'no pain,' 5 referred to 'moderate pain,' and ten referred to 'excruciating pain.' The patients were asked to mark their pain intensities on the VAS scale.
Baseline Pain intensity with McGill pain questionnaire
Time frame: At the initial visit before arthrocentesis procedure.
The pain intensity measurement was performed with the McGill Pain Questionnaire form. According to the word groups chosen by the participants, the total score of the questionnaire varies between 0-78. An increase in the total score is interpreted as the severity of pain intensity.
Change From Baseline Maximum Mouth Opening on Postoperative Follow Up Visits
Time frame: At the initial visit, at the session of arthrocentesis postoperatively, at the first week
All patients' maximal mouth opening were measured and recorded as the distance between upper and lower right central incisors.
Postoperative Pain intensity with Visual analog scale
Time frame: At first week follow-up visit
The pain intensity measurement was performed with the Visual analog scale (VAS), in which 0 referred to 'no pain,' 5 referred to 'moderate pain,' and ten referred to 'excruciating pain.' The patients were asked to mark their pain intensities on the VAS scale.
Postoperative Pain intensity with McGill pain questionnaire
Time frame: At first week follow-up visit
The pain intensity measurements were performed with the McGill Pain Questionnaire form. According to the word groups chosen by the participants, the total score of the questionnaire varies between 0-78. An increase in the total score is interpreted as the severity of pain intensity.
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 4 Jan 2023.
- Background: PubMed 33028488Hosgor H. Is arthrocentesis plus hyaluronic acid superior to arthrocentesis alone in the treatment of disc displacement without reduction in patients with bruxism? J Craniomaxillofac Surg. 2020 Nov;48(11):1023-1027. doi: 10.1016/j.jcms.2020.07.008. Epub 2020 Jul 25.
- Results publication: PubMed 28222947Tatli U, Benlidayi ME, Ekren O, Salimov F. Comparison of the effectiveness of three different treatment methods for temporomandibular joint disc displacement without reduction. Int J Oral Maxillofac Surg. 2017 May;46(5):603-609. doi: 10.1016/j.ijom.2017.01.018. Epub 2017 Feb 20.
- Derived from this study: PubMed 36918123Erdil A, Demirsoy MS, Tumer MK. Evaluation of the effects of arthrocentesis combined with occlusal stabilization splint on disc displacement without reduction-induced acute and closed lock. A prospective cohort study. J Stomatol Oral Maxillofac Surg. 2023 Oct;124(5):101438. doi: 10.1016/j.jormas.2023.101438. Epub 2023 Mar 12.
- Individual participant dataSharing planned: No. The data regarding participants were made available in the manuscript
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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.
Mehmet K. Tümer, AssocProfDr study director
Alanya Alaaddin Keykubat University
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 of the temporomandibular joint in people with Temporomandibular Joint Disorders, run by Tokat Gaziosmanpasa 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 6 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 4 Jan 2023. 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?
Baseline Pain intensity with Visual analog scale (time frame: At the initial visit before arthrocentesis procedure.). The study lists 5 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 NCT05671549, which also lists 3 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 4 Jan 2023.