Temporomandibular Joint DisordersExeTMJArthroNCT06756412
The Effects of an Exercise Regimen Following TMJ Arthrocentesis
An observational study of Temporomandibular Joint Disorders, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study is to evaluate the short- and long-term effects of a self-administered exercise program on pain levels, jaw movement range, and jaw function in patients with temporomandibular joint (TMJ) disorders. 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?
- Temporomandibular Joint Arthrocentesis and Self Exercise Following Arthrocentesis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jun 2023to 16 Jul 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
Study population: Admitted patients with the history of limited mouth opening and TMJ arthralgia
Who may be able to join
- Limited mouth opening (<35mm) and joint pain complaints according to the DC/TMD examination form,
- Pain complaints for 3 months or longer,
- Able to understand Turkish in spoken and written language,
- Patients who can read the written consent form and give signed consent will be included in the study.
Who cannot join
- Those with serious neurological disorders,
- Those with autoimmune disorders involving muscles or joints,
- Those with a history of alcoholism,
- Patients diagnosed with malignancy,
- Patients who have previously undergone surgery or radiotherapy in the head and neck region,
- Those with other TMD diagnoses that do not cause restriction or pain in mouth opening,
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- Those who have received other treatments for the neck or TMJ regions in the last 3 months,
- Those with a history of surgical treatment for the temporomandibular joint,
- Those with a history of allergy to any of the agents used in the treatment process,
- Those who use drugs that affect the musculoskeletal system, and
- Pregnant patients will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Uşak University, Faculty of Dentistry
Uşak, 64200
About this study
Official title: Investigation of the Efficacy of an Exercise Regimen Following Arthrocentesis in the Management of Temporomandibular Disorders
The goal of this study is to evaluate the short- and long-term effects of a self-administered exercise program on pain levels, jaw movement range, and jaw function in patients with temporomandibular joint (TMJ) disorders. The main question it aims to answer is:
Does adding a self-administered exercise program to arthrocentesis improve pain, mouth opening, and jaw function compared to arthrocentesis alone in patients with TMJ disorders?
Participants with acute or chronic TMJ pain lasting at least three months and limited mouth opening will undergo arthrocentesis, with one group also following an exercise regimen. Outcomes will be assessed over a 6-month follow-up period.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Temporomandibular Joint Arthrocentesis, Self Exercise Following Arthrocentesis
- Keywords
- Temporomandibular Joint Disorders, Arthrocentesis, Temporomandibular joint, Exercise Therapy
- 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.
Temporomandibular Joint ArthrocentesisProcedure or surgery
The symptomatic temporomandibular joint (TMJ), either right or left, will be anesthetized using an auriculotemporal nerve block and intracapsular anesthesia. The arthrocentesis procedure will be performed using the double-puncture technique. A 21-gauge needle will be inserted into the posterior region of the joint capsule, targeting the upper joint compartment at a point located 10 mm anterior to the tragus. A second 21-gauge needle will be introduced into the anterior region of the joint capsule, also targeting the upper compartment, at a point located 20 mm anterior to the tragus. The upper joint compartment will then be irrigated with a minimum of 200 mL of saline solution through one of the needles.
Self Exercise Following ArthrocentesisProcedure or surgery
Following the arthrocentesis procedure described for the other study group, patients will undergo a standardized exercise regimen based on established literature. The regimen includes two sets of movements. The first set involves freely opening the jaw, shifting it right, left, and forward, and repeating these movements while applying finger resistance-closing the mouth against the pressure or forcing the jaw open with the fingers. Each movement will last 10 seconds and be performed 10 times daily. The second set aims to improve the mandibular condyle-articular disc relationship. Patients will open their mouth as wide as possible, advance their lower jaw fully, and close their teeth in an edge-to-edge position. These movements will be performed three times daily for 5 minutes after meals.
| Study group | Role | What they receive |
|---|---|---|
| Arthrocentesis Group | Patients with arthralgia and limited mouth opening at least 3 moths, if volunteered, will be enrolled to this group. The patients will undertake a TMJ arthrocentesis, will be recommended behavioural modifications and diet alterations. Receives: Procedure: Temporomandibular Joint Arthrocentesis | |
| Self-Exercise Following TMJ Arthrocentesis | Patients with arthralgia and limited mouth opening at least 3 moths will be enrolled to this group. The patients, if volunteered, will undertake a TMJ arthrocentesis, will be recommended behavioural modifications and diet alterations. Following the arthrocentesis procedure, the patients will be instructed an exercise regimen adopted from the current literature, and asked to perform the regimen for postoperative six weeks. Receives: Procedure: Self Exercise Following Arthrocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Amount of Mouth Opening
For mouth opening measurement, the distance between the incisal edges of the lower and upper first incisors will be measured using a digital caliper and will be recorded in millimeters at the end of each examination. In patients with missing teeth, the teeth on the left side will be used for the measurement. In order to determine the amount of movement of the lower jaw in the lateral direction, patients will be asked to shift their lower jaws to the right and left. The amount of displacement of the midline of the lower jaw teeth relative to the midline of the upper jaw teeth will be measured with a digital caliper. The distances obtained will be recorded in millimeters at the end of each examination.
Measured: Measurements will be conducted at five time points, from enrollment through the 6-month follow-up period: (1) pre-arthrocentesis, (2) postoperative 1st week, (3) postoperative 1st month, (4) postoperative 3rd month, and (5) postoperative 6th month.
Pain Intensity
A visual analog scale (VAS) will be used to measure pain intensity. The scale consists of a 10-centimeter straight line, with '0' at the starting point indicating no pain and '10' at the endpoint representing the highest pain level tolerable. During each examination session, individuals will mark the point on the line that corresponds to their pain intensity. The distance from the '0' point to the marked position will be measured in centimeters, with greater distances indicating higher pain intensity.
Measured: Measurements will be conducted at five time points, from enrollment through the 6-month follow-up period: (1) pre-arthrocentesis, (2) postoperative 1st week, (3) postoperative 1st month, (4) postoperative 3rd month, and (5) postoperative 6th month.
Secondary outcomes (1)
Jaw Function Limitation
The Jaw Function Limitation Scale (JFLS-20) will be administered to patients during all examination sessions using a standardized form. This scale assesses the extent to which daily activities are restricted by TMD symptoms. It includes 20 jaw functions, each scored by the patient on a scale from 0 to 10, where '0' indicates no impact and '10' indicates extreme difficulty performing the function due to TMD. The individual scores are summed to calculate a total score, with higher scores indicating greater limitations in jaw function.
Measured: Measurements will be conducted at five time points, from enrollment through the 6-month follow-up period: (1) pre-arthrocentesis, (2) postoperative 1st week, (3) postoperative 1st month, (4) postoperative 3rd month, and (5) postoperative 6th month.
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 start8 Jun 2023
- Primary completion15 Jan 2024
- Study completion16 Jul 2024
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
- Target duration
- 6 Months
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 A Güngör, Prof Dr, Study director, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756412
- Sponsor's protocol ID
- UsakU
- Acronym
- ExeTMJArthro
- Status last verified
- Dec 2024
- First submitted
- 25 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
- Yes: Individual participant data (IPD) will be made available upon request from the corresponding researcher following the publication of the study.
Publications
Lindfors E, Arima T, Baad-Hansen L, Bakke M, De Laat A, Giannakopoulos NN, Glaros A, Guimaraes AS, Johansson A, Le Bell Y, Lobbezoo F, Michelotti A, Muller F, Ohrbach R, Wanman A, Magnusson T, Ernberg M. Jaw Exercises in the Treatment of Temporomandibular Disorders-An International Modified Delphi Study. J Oral Facial Pain Headache. 2019 Fall;33(4):389-398. doi: 10.11607/ofph.2359. Epub 2019 Jun 24.
PubMed 31247061Hosgor H, Bas B, Celenk C. A comparison of the outcomes of four minimally invasive treatment methods for anterior disc displacement of the temporomandibular joint. Int J Oral Maxillofac Surg. 2017 Nov;46(11):1403-1410. doi: 10.1016/j.ijom.2017.05.010. Epub 2017 Jun 9.
PubMed 28602569Bas B, Kazan D, Kutuk N, Gurbanov V. The Effect of Exercise on Range of Movement and Pain After Temporomandibular Joint Arthrocentesis. J Oral Maxillofac Surg. 2018 Jun;76(6):1181-1186. doi: 10.1016/j.joms.2018.01.003. Epub 2018 Jan 12.
PubMed 29406255
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
- Investigation of the Efficacy of an Exercise Regimen Following Arthrocentesis in the Management of Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT06756412
- Acronym / sponsor ID
- ExeTMJArthro / UsakU
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Temporomandibular Joint Disorders, Arthrocentesis, Temporomandibular joint, Exercise Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 16 Jul 2024 (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 goal of this study is to evaluate the short- and long-term effects of a self-administered exercise program on pain levels, jaw movement range, and jaw function in patients with temporomandibular joint (TMJ) disorders. The main question it aims to answer is:
Does adding a self-administered exercise program to arthrocentesis improve pain, mouth opening, and jaw function compared to arthrocentesis alone in patients with TMJ disorders?
Participants with acute or chronic TMJ pain lasting at least three months and limited mouth opening will undergo arthrocentesis, with one group also following an exercise regimen. Outcomes will be assessed over a 6-month follow-up period.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthrocentesis Group | – | Procedure: Temporomandibular Joint ArthrocentesisPatients with arthralgia and limited mouth opening at least 3 moths, if volunteered, will be enrolled to this group. The patients will undertake a TMJ arthrocentesis, will be recommended behavioural modifications and diet alterations. |
| Self-Exercise Following TMJ Arthrocentesis | – | Procedure: Self Exercise Following ArthrocentesisPatients with arthralgia and limited mouth opening at least 3 moths will be enrolled to this group. The patients, if volunteered, will undertake a TMJ arthrocentesis, will be recommended behavioural modifications and diet alterations. Following the arthrocentesis procedure, the patients will be instructed an exercise regimen adopted from the current literature, and asked to perform the regimen for postoperative six weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Admitted patients with the history of limited mouth opening and TMJ arthralgia
Key inclusion criteria (4 listed)
- Limited mouth opening (<35mm) and joint pain complaints according to the DC/TMD examination form,
- Pain complaints for 3 months or longer,
- Able to understand Turkish in spoken and written language,
- Patients who can read the written consent form and give signed consent will be included in the study.
Key exclusion criteria (11 listed)
- Those with serious neurological disorders,
- Those with autoimmune disorders involving muscles or joints,
- Those with a history of alcoholism,
- Patients diagnosed with malignancy,
- Patients who have previously undergone surgery or radiotherapy in the head and neck region,
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 |
|---|---|---|
| Temporomandibular Joint ArthrocentesisThe symptomatic temporomandibular joint (TMJ), either right or left, will be anesthetized using an auriculotemporal nerve block and intracapsular anesthesia. The arthrocentesis procedure will be performed using the double-puncture technique. A 21-gauge needle will be inserted into the posterior region of the joint capsule, targeting the upper joint compartment at a point located 10 mm anterior to the tragus. A second 21-gauge needle will be introduced into the anterior region of the joint capsule, also targeting the upper compartment, at a point located 20 mm anterior to the tragus. The upper joint compartment will then be irrigated with a minimum of 200 mL of saline solution through one of the needles. | Procedure or surgery | Arthrocentesis Group |
| Self Exercise Following ArthrocentesisFollowing the arthrocentesis procedure described for the other study group, patients will undergo a standardized exercise regimen based on established literature. The regimen includes two sets of movements. The first set involves freely opening the jaw, shifting it right, left, and forward, and repeating these movements while applying finger resistance-closing the mouth against the pressure or forcing the jaw open with the fingers. Each movement will last 10 seconds and be performed 10 times daily. The second set aims to improve the mandibular condyle-articular disc relationship. Patients will open their mouth as wide as possible, advance their lower jaw fully, and close their teeth in an edge-to-edge position. These movements will be performed three times daily for 5 minutes after meals. | Procedure or surgery | Self-Exercise Following TMJ Arthrocentesis |
Primary outcome
Maximum Amount of Mouth Opening
Time frame: Measurements will be conducted at five time points, from enrollment through the 6-month follow-up period: (1) pre-arthrocentesis, (2) postoperative 1st week, (3) postoperative 1st month, (4) postoperative 3rd month, and (5) postoperative 6th month.
For mouth opening measurement, the distance between the incisal edges of the lower and upper first incisors will be measured using a digital caliper and will be recorded in millimeters at the end of each examination. In patients with missing teeth, the teeth on the left side will be used for the measurement. In order to determine the amount of movement of the lower jaw in the lateral direction, patients will be asked to shift their lower jaws to the right and left. The amount of displacement of the midline of the lower jaw teeth relative to the midline of the upper jaw teeth will be measured with a digital caliper. The distances obtained will be recorded in millimeters at the end of each examination.
Pain Intensity
Time frame: Measurements will be conducted at five time points, from enrollment through the 6-month follow-up period: (1) pre-arthrocentesis, (2) postoperative 1st week, (3) postoperative 1st month, (4) postoperative 3rd month, and (5) postoperative 6th month.
A visual analog scale (VAS) will be used to measure pain intensity. The scale consists of a 10-centimeter straight line, with '0' at the starting point indicating no pain and '10' at the endpoint representing the highest pain level tolerable. During each examination session, individuals will mark the point on the line that corresponds to their pain intensity. The distance from the '0' point to the marked position will be measured in centimeters, with greater distances indicating higher pain intensity.
1 secondary outcome
Jaw Function Limitation
Time frame: Measurements will be conducted at five time points, from enrollment through the 6-month follow-up period: (1) pre-arthrocentesis, (2) postoperative 1st week, (3) postoperative 1st month, (4) postoperative 3rd month, and (5) postoperative 6th month.
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 31247061Lindfors E, Arima T, Baad-Hansen L, Bakke M, De Laat A, Giannakopoulos NN, Glaros A, Guimaraes AS, Johansson A, Le Bell Y, Lobbezoo F, Michelotti A, Muller F, Ohrbach R, Wanman A, Magnusson T, Ernberg M. Jaw Exercises in the Treatment of Temporomandibular Disorders-An International Modified Delphi Study. J Oral Facial Pain Headache. 2019 Fall;33(4):389-398. doi: 10.11607/ofph.2359. Epub 2019 Jun 24.
- Background: PubMed 28602569Hosgor H, Bas B, Celenk C. A comparison of the outcomes of four minimally invasive treatment methods for anterior disc displacement of the temporomandibular joint. Int J Oral Maxillofac Surg. 2017 Nov;46(11):1403-1410. doi: 10.1016/j.ijom.2017.05.010. Epub 2017 Jun 9.
- Background: PubMed 29406255Bas B, Kazan D, Kutuk N, Gurbanov V. The Effect of Exercise on Range of Movement and Pain After Temporomandibular Joint Arthrocentesis. J Oral Maxillofac Surg. 2018 Jun;76(6):1181-1186. doi: 10.1016/j.joms.2018.01.003. Epub 2018 Jan 12.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be made available upon request from the corresponding researcher following the publication 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.
Mehmet A Güngör, Prof Dr study director
Uşak University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 11 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?
Maximum Amount of Mouth Opening (time frame: Measurements will be conducted at five time points, from enrollment through the 6-month follow-up period: (1) pre-arthrocentesis, (2) postoperative 1st week, (3) postoperative 1st month, (4) postoperative 3rd month, and (5) postoperative 6th month.). 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 NCT06756412, 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 3 Jan 2025.