Temporomandibular Joint DysfunctionNCT06526845
Effectiveness of Telerehabilitation in Individuals With Temporomandibular Joint Dysfunction and Myofascial Pain
A study testing Video-Conference based rehabilitation and Home-Based rehabilitation in people with Temporomandibular Joint Dysfunction and Myofascial Pain, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
Telerehabilitation is a treatment method that allows the patient to access treatment remotely, regardless of where they are, thanks to developing technology. Telerehabilitation provides us with opportunities such as patient evaluation, monitoring, therapy, consultation, education and patient follow-up. 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 Dysfunction, Myofascial Pain
- What is being tested?
- Video-Conference based rehabilitation and Home-Based rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jul 2024to 30 Dec 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
- People between the ages of 18-65 with myofascial temporomandibular pain
- Displacement of the disc with anterior reduction,
- Pain in the masticatory muscle/temporomandibular area lasting more than a month
- Symptoms lasting at least three months,
- People who have the opportunity to provide informed consent and participate in treatment and evaluation clinics.
Who cannot join
- Anterior disc displacement without reduction,
- Primary arthrogenic pain,
- Other temporomandibular disorders,
- Neurological or psychiatric disorders,
- People who have had temporomandibular joint and/or cervical spine surgery,
- Abuse of painkillers or abuse of existing medication.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Buket AKINCI
Istanbul, 34010
Buket AKINCI, Assoc.Prof., +90 212 409 12 12 ext. 1208, barbuket@hotmail.com
Naile Fazlıoğlu, PT, +90 5349263129, nailefazlioglu@gmail.com
About this study
Official title: Examining The Effectiveness of Telerehabilitation in Individuals With Temporomandibular Joint Dysfunction and Myofascial Pain
Telerehabilitation is a treatment method that allows the patient to access treatment remotely, regardless of where they are, thanks to developing technology. Telerehabilitation provides us with opportunities such as patient evaluation, monitoring, therapy, consultation, education and patient follow-up. Within the scope of our study, the effects of applying an exercise program to patients through a home exercise program and telerehabilitation will be investigated. The purpose of this study for individuals with temporomandibular joint dysfunction is; To investigate the effectiveness of exercises for myofascial pain through telerehabilitation in individuals with myofascial pain and TMJ dysfunction.
Read the detailed description
TMJ, one of the most complex joints of the body, is a ginglimoarthrodial joint located in the front part of the external auditory canal, between the mandibular fossa (glenoid fossa) of the temporal bone and the condylar processes of the mandible, and also performs rotation and sliding movements. It is composed of fibrous connective tissue between the bone tissues that form the joint. There is a joint disc that divides the joint space into two parts, lower and upper. TMJ is effective in basic functions such as providing mandibular movement, speaking and chewing. A normal person uses TMJ a lot in daily life. For this reason, pathologies related to TMJ are encountered more frequently than other joints in the body. Clinical signs and symptoms of temporomandibular joint disorders may vary, but pain, noise from the joint, limitation of mandibular movements and tenderness in the chewing muscles are among the most frequently observed symptoms. It has been shown in many studies that the daily living activities of individuals with TMJ dysfunction are negatively affected, and this affects the quality of life of individuals. Therefore, identification, diagnosis and treatment of symptoms are important. Many methods such as analgesic and anti-inflammatory drugs, splint therapy, exercise and physical therapy modalities are used in the treatment of these individuals. When looking at the literature, it is seen that exercise therapy has an important place in TMJ rehabilitation and that a supervised rehabilitation program is effective in improving functional parameters. In the studies of Çapan et al., it was seen that active exercise and relaxation exercises applied to the chewing muscle groups were an effective treatment method on deviation and pain. Bae et al. showed that manual therapy and exercise applications for the cervical region had positive effects on pain threshold in chewing muscles and pain-free mouth opening in patients with myofascial type TMD. In a systematic review published in 2014, joint mobilization, soft tissue mobilization and friction massage were recommended to reduce pain, increase normal joint movement (ROM) and reduce other symptoms within the scope of manual therapy techniques (MTT) for TMJ problems. Especially in soft tissue mobilization, the method called pressure trigger point release technique; It is a noninvasive method based on gradually applying pressure on the trigger point in accordance with the patient's tolerance. Exercise is one of the approaches that have been used for a long time in the treatment of TMJ problems. Therapeutic exercises specific to TMJ problems can be used to specifically improve the functions between the TMJ and the craniomandibular system. Most exercise programs have an important place in increasing muscle coordination, normalizing range of motion, providing muscle relaxation and increasing muscle strength.
Telerehabilitation is a treatment method that allows the patient to access treatment remotely, regardless of where they are, thanks to developing technology. Telerehabilitation provides us with opportunities such as patient evaluation, monitoring, therapy, consultation, education and patient follow-up. Within the scope of our study, the effects of applying an exercise program to patients through home exercise program and telerehabilitation will be investigated.
The purpose of this study for individuals with temporomandibular joint dysfunction; To investigate the effectiveness of exercises for myofascial pain through telerehabilitation in individuals with myofascial pain and TMJ dysfunction.
- Being tested
- Video-Conference based rehabilitation, Home-Based rehabilitation
- Keywords
- Temporomandibular Joint Disorders, Telerehabilitation, Exercise
- Medical subject headings
- Temporomandibular Joint Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Conference based rehabilitationOther
All exercises in the brochure will be performed by patients via telerehabilitation. The exercises included in the exercise package are as follows:
- Post-isometric relaxation exercise and relaxation exercise with diaphragmatic breathing
- Neck Exercises: 5 neck exercises including cervical isometric flexion, extension, right and left lateral flexion and chin tuck exercises.
- Soft tissue-friction massage: It will be applied to the area where myofascial pain develops due to TMJD.
- Mandibular mobility exercises: opening and closing the mouth slowly and rhythmically, lateral movements, protrusion movement, hold-relax technique, jaw isometric exercises
- Stretching exercises: Stretching exercises for chewing muscles (masseter muscle stretching, temporalis muscle stretching, pterygoid muscle stretching).
Home-Based rehabilitationOther
Patient education will be provided by showing all exercises in practice. Brochures will then be given to patients so they can apply them at home. The exercises in the brochure are as follows;
- Post-isometric relaxation exercise and relaxation exercise with diaphragmatic breathing
- Neck Exercises: 5 neck exercises including cervical isometric flexion, extension, right and left lateral flexion and chin tuck exercises.
- Soft tissue-friction massage: It will be applied to the area where myofascial pain develops due to TMJD.
- Mandibular mobility exercises: opening and closing the mouth slowly and rhythmically, lateral movements, protrusion movement, hold-relax technique, jaw isometric exercises
- Stretching exercises: Stretching exercises for chewing muscles (masseter muscle stretching, temporalis muscle stretching, pterygoid muscle stretching).
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Group | Experimental | All exercises in the brochure will be performed by patients via telerehabilitation.It will be applied twice a week for 6 weeks. Receives: Other: Video-Conference based rehabilitation |
| Home-Based Exercise Group | Active comparator | Patient education will be provided by showing all the exercises in practice. Then, brochures will be given to the patients so that they can practice them at home.It will be applied twice a week for 6 weeks. Receives: Other: Home-Based rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fonseca Anamnestic Index
Temporomandibular dysfunction is assessed using the Fonseca Anamnestic Index .
Measured: Change from Fonseca Anamnestic Index at 6 weeks.
Visual Analogue Scale
Participants; It is performed to evaluate jaw and facial pain when waking up in the morning, during the day, at bedtime, when chewing and at rest.
Visual Analogue Scale includes scoring between 0-10. The minimum value is 0 score - no pain; The maximum score of 10 indicates unbearable pain. A higher score means more pain and a worse outcome.
Measured: Change from Visual Analog Scale at 6 weeks.
Painless Maximum Mouth Opening
It will be done to evaluate the painless maximum mouth opening of the participants.
It will be performed to evaluate the pain-free maximum mouth opening of the participants.
The patient will be asked to open his mouth as far as possible and the distance between the lower and upper incisors will be measured with a millimeter ruler. The result will be recorded in mm.
Measured: Change from Painless Maximum Mouth Opening at 6 weeks.
Painful Maximum Mouth Opening
It will be performed to evaluate the participants' maximum mouth opening with pain.
The patient will be asked to open his mouth to the last painful point and the distance between the lower and upper incisors will be measured with a millimeter ruler. The result will be recorded in mm.
Measured: Change from Painful Maximum Mouth Opening at 6 weeks.
Maximum Mouth Opening With Passive Assistance
It will be carried out to evaluate the maximum mouth opening of the participants with passive assistance (dentist or physiotherapist).
The patient will be asked to open his mouth as far as possible with the support of a dentist or physiotherapist, and the distance between the lower and upper incisors will be measured with a millimeter ruler. The result will be recorded in mm.
Measured: Change from Maximum Mouth Opening With Passive Assistance at 6 weeks.
Mandibula Lateral Shift
It evaluates the right and left shifts of the mandibula in participants. The patient first moves his lower jaw to the right and how far it moves from the midline is measured with a millimetric ruler. The measured value is recorded in millimeters. Then, the same process is performed for the left side.
Measured: Change from Mandibula Lateral Shift at 6 weeks.
Oral Health Impact Profile-14 (OHIP-14)
It evaluates the quality of life in temporomandibular joint dysfunction. The total score varies between 0-84. A high score indicates that you have bad oral habits.
Measured: Change from Oral Health Impact Profile-14 (OHIP-14) at 6 weeks.
Secondary outcomes (3)
Oral Behaviour Checklist
It is applied to evaluate the oral behaviour of the participants.
Measured: Change from Oral Behaviour Checklist at 6 weeks.
Cervical Region Joint Range of Motion
It will be applied to evaluate the participants cervical region flexion, extension, right and left lateral flexion, and right and left rotation degrees.
Measured: Change from Cervical Region Joint Range of Motion at 6 weeks.
Neck Disability Index
The NDI measures self-reported pain intensity (pain, headache) and limitations in performing daily work-related activities (work, lifting and concentration) and non-work-related activities (personal care, reading, driving, sleeping and leisure).
Measured: Change from Neck Disability Index at 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start23 Jul 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
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 DysfunctionStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Bezmialem Vakif University
- Responsible party
- Principal investigator, Buket AKINCI, Biruni University
- Investigators
- Buket AKINCI, Assoc.Prof., Study director, ConsultorNükhet KÜTÜK, Prof., Study chair, study chairBeliz SERDAROĞLU, Dt., Study chair, study chairNaile FAZLIOĞLU, PT., Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526845
- Sponsor's protocol ID
- E-54022451-050.04-144681
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will be shared during the publication process if the journal will ask.
Publications
Fazlioglu N, Kara Kaya B, Kutuk N, Akinci B. Effectiveness of Telerehabilitation in Individuals With Myofascial Pain and Temporomandibular Joint Dysfunction: A Randomized Controlled Trial. J Oral Rehabil. 2026 Jun 8. doi: 10.1111/joor.70232. Online ahead of print.
PubMed 42260909
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining The Effectiveness of Telerehabilitation in Individuals With Temporomandibular Joint Dysfunction and Myofascial Pain
- ClinicalTrials.gov ID
- NCT06526845
- Acronym / sponsor ID
- E-54022451-050.04-144681
- Keywords
- Temporomandibular Joint Disorders, Telerehabilitation, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Bezmialem Vakif University
- Study start
- 23 Jul 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 30 Jul 2024 (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.
Telerehabilitation is a treatment method that allows the patient to access treatment remotely, regardless of where they are, thanks to developing technology. Telerehabilitation provides us with opportunities such as patient evaluation, monitoring, therapy, consultation, education and patient follow-up. Within the scope of our study, the effects of applying an exercise program to patients through a home exercise program and telerehabilitation will be investigated. The purpose of this study for individuals with temporomandibular joint dysfunction is; To investigate the effectiveness of exercises for myofascial pain through telerehabilitation in individuals with myofascial pain and TMJ dysfunction.
Detailed description
TMJ, one of the most complex joints of the body, is a ginglimoarthrodial joint located in the front part of the external auditory canal, between the mandibular fossa (glenoid fossa) of the temporal bone and the condylar processes of the mandible, and also performs rotation and sliding movements. It is composed of fibrous connective tissue between the bone tissues that form the joint. There is a joint disc that divides the joint space into two parts, lower and upper. TMJ is effective in basic functions such as providing mandibular movement, speaking and chewing. A normal person uses TMJ a lot in daily life. For this reason, pathologies related to TMJ are encountered more frequently than other joints in the body. Clinical signs and symptoms of temporomandibular joint disorders may vary, but pain, noise from the joint, limitation of mandibular movements and tenderness in the chewing muscles are among the most frequently observed symptoms. It has been shown in many studies that the daily living activities of individuals with TMJ dysfunction are negatively affected, and this affects the quality of life of individuals. Therefore, identification, diagnosis and treatment of symptoms are important. Many methods such as analgesic and anti-inflammatory drugs, splint therapy, exercise and physical therapy modalities are used in the treatment of these individuals. When looking at the literature, it is seen that exercise therapy has an important place in TMJ rehabilitation and that a supervised rehabilitation program is effective in improving functional parameters. In the studies of Çapan et al., it was seen that active exercise and relaxation exercises applied to the chewing muscle groups were an effective treatment method on deviation and pain. Bae et al. showed that manual therapy and exercise applications for the cervical region had positive effects on pain threshold in chewing muscles and pain-free mouth opening in patients with myofascial type TMD. In a systematic review published in 2014, joint mobilization, soft tissue mobilization and friction massage were recommended to reduce pain, increase normal joint movement (ROM) and reduce other symptoms within the scope of manual therapy techniques (MTT) for TMJ problems. Especially in soft tissue mobilization, the method called pressure trigger point release technique; It is a noninvasive method based on gradually applying pressure on the trigger point in accordance with the patient's tolerance. Exercise is one of the approaches that have been used for a long time in the treatment of TMJ problems. Therapeutic exercises specific to TMJ problems can be used to specifically improve the functions between the TMJ and the craniomandibular system. Most exercise programs have an important place in increasing muscle coordination, normalizing range of motion, providing muscle relaxation and increasing muscle strength.
Telerehabilitation is a treatment method that allows the patient to access treatment remotely, regardless of where they are, thanks to developing technology. Telerehabilitation provides us with opportunities such as patient evaluation, monitoring, therapy, consultation, education and patient follow-up. Within the scope of our study, the effects of applying an exercise program to patients through home exercise program and telerehabilitation will be investigated.
The purpose of this study for individuals with temporomandibular joint dysfunction; To investigate the effectiveness of exercises for myofascial pain through telerehabilitation in individuals with myofascial pain and TMJ dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Group | Experimental | Other: Video-Conference based rehabilitationAll exercises in the brochure will be performed by patients via telerehabilitation.It will be applied twice a week for 6 weeks. |
| Home-Based Exercise Group | Active comparator | Other: Home-Based rehabilitationPatient education will be provided by showing all the exercises in practice. Then, brochures will be given to the patients so that they can practice them at home.It will be applied twice a week for 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- People between the ages of 18-65 with myofascial temporomandibular pain
- Displacement of the disc with anterior reduction,
- Pain in the masticatory muscle/temporomandibular area lasting more than a month
- Symptoms lasting at least three months,
- People who have the opportunity to provide informed consent and participate in treatment and evaluation clinics.
Key exclusion criteria (6 listed)
- Anterior disc displacement without reduction,
- Primary arthrogenic pain,
- Other temporomandibular disorders,
- Neurological or psychiatric disorders,
- People who have had temporomandibular joint and/or cervical spine surgery,
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 |
|---|---|---|
| Video-Conference based rehabilitationAll exercises in the brochure will be performed by patients via telerehabilitation. The exercises included in the exercise package are as follows: * Post-isometric relaxation exercise and relaxation exercise with diaphragmatic breathing * Neck Exercises: 5 neck exercises including cervical isometric flexion, extension, right and left lateral flexion and chin tuck exercises. * Soft tissue-friction massage: It will be applied to the area where myofascial pain develops due to TMJD. * Mandibular mobility exercises: opening and closing the mouth slowly and rhythmically, lateral movements, protrusion movement, hold-relax technique, jaw isometric exercises * Stretching exercises: Stretching exercises for chewing muscles (masseter muscle stretching, temporalis muscle stretching, pterygoid muscle stretching). | Other | Telerehabilitation Group |
| Home-Based rehabilitationPatient education will be provided by showing all exercises in practice. Brochures will then be given to patients so they can apply them at home. The exercises in the brochure are as follows; * Post-isometric relaxation exercise and relaxation exercise with diaphragmatic breathing * Neck Exercises: 5 neck exercises including cervical isometric flexion, extension, right and left lateral flexion and chin tuck exercises. * Soft tissue-friction massage: It will be applied to the area where myofascial pain develops due to TMJD. * Mandibular mobility exercises: opening and closing the mouth slowly and rhythmically, lateral movements, protrusion movement, hold-relax technique, jaw isometric exercises * Stretching exercises: Stretching exercises for chewing muscles (masseter muscle stretching, temporalis muscle stretching, pterygoid muscle stretching). | Other | Home-Based Exercise Group |
Primary outcome
Fonseca Anamnestic Index
Time frame: Change from Fonseca Anamnestic Index at 6 weeks.
Temporomandibular dysfunction is assessed using the Fonseca Anamnestic Index .
Visual Analogue Scale
Time frame: Change from Visual Analog Scale at 6 weeks.
Participants; It is performed to evaluate jaw and facial pain when waking up in the morning, during the day, at bedtime, when chewing and at rest. Visual Analogue Scale includes scoring between 0-10. The minimum value is 0 score - no pain; The maximum score of 10 indicates unbearable pain. A higher score means more pain and a worse outcome.
Painless Maximum Mouth Opening
Time frame: Change from Painless Maximum Mouth Opening at 6 weeks.
It will be done to evaluate the painless maximum mouth opening of the participants. It will be performed to evaluate the pain-free maximum mouth opening of the participants. The patient will be asked to open his mouth as far as possible and the distance between the lower and upper incisors will be measured with a millimeter ruler. The result will be recorded in mm.
Painful Maximum Mouth Opening
Time frame: Change from Painful Maximum Mouth Opening at 6 weeks.
It will be performed to evaluate the participants' maximum mouth opening with pain. The patient will be asked to open his mouth to the last painful point and the distance between the lower and upper incisors will be measured with a millimeter ruler. The result will be recorded in mm.
Maximum Mouth Opening With Passive Assistance
Time frame: Change from Maximum Mouth Opening With Passive Assistance at 6 weeks.
It will be carried out to evaluate the maximum mouth opening of the participants with passive assistance (dentist or physiotherapist). The patient will be asked to open his mouth as far as possible with the support of a dentist or physiotherapist, and the distance between the lower and upper incisors will be measured with a millimeter ruler. The result will be recorded in mm.
Mandibula Lateral Shift
Time frame: Change from Mandibula Lateral Shift at 6 weeks.
It evaluates the right and left shifts of the mandibula in participants. The patient first moves his lower jaw to the right and how far it moves from the midline is measured with a millimetric ruler. The measured value is recorded in millimeters. Then, the same process is performed for the left side.
Oral Health Impact Profile-14 (OHIP-14)
Time frame: Change from Oral Health Impact Profile-14 (OHIP-14) at 6 weeks.
It evaluates the quality of life in temporomandibular joint dysfunction. The total score varies between 0-84. A high score indicates that you have bad oral habits.
3 secondary outcomes
Oral Behaviour Checklist
Time frame: Change from Oral Behaviour Checklist at 6 weeks.
Cervical Region Joint Range of Motion
Time frame: Change from Cervical Region Joint Range of Motion at 6 weeks.
Neck Disability Index
Time frame: Change from Neck Disability Index at 6 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 42260909Fazlioglu N, Kara Kaya B, Kutuk N, Akinci B. Effectiveness of Telerehabilitation in Individuals With Myofascial Pain and Temporomandibular Joint Dysfunction: A Randomized Controlled Trial. J Oral Rehabil. 2026 Jun 8. doi: 10.1111/joor.70232. Online ahead of print.
- Individual participant dataSharing planned: Undecided. The data will be shared during the publication process if the journal will ask.
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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.
Buket AKINCI, Assoc.Prof. study director
Consultor
Nükhet KÜTÜK, Prof. study chair
study chair
Beliz SERDAROĞLU, Dt. study chair
study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-Conference based rehabilitation and Home-Based rehabilitation in people with Temporomandibular Joint Dysfunction and Myofascial Pain, run by Biruni 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 5 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: status not confirmed, as of the sponsor's last update on 30 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Buket AKINCI, Assoc.Prof. (02124091212 ext. 1208, barbuket@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fonseca Anamnestic Index (time frame: Change from Fonseca Anamnestic Index at 6 weeks.). The study lists 7 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 NCT06526845, 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 30 Jul 2024.