Temporomandibular DisorderPhase 4NCT05529290
Evaluation of the Efficacy of Different Drugs in the Treatment of the Pain in Patients With Temporomandibular Disorder
A Phase 4 study testing Dexketoprofen Trometamol + Thiocolchicoside, Dexketoprofen Trometamol + Paracetamol and Dexketoprofen Trometamol (25mg) in people with Temporomandibular Disorder, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
The most important step in the treatment of TMJ (temporomandibular joint) disease in clinical dentistry is diagnosis and planning. The clinical findings, drug requirement and biological risk of the patients determine the examination methods to be used in the Treatment of Temporomandibular Joint Disorders. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Dexketoprofen Trometamol + Thiocolchicoside, Dexketoprofen Trometamol + Paracetamol and Dexketoprofen Trometamol (25mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jul 2019to 1 Feb 2022
- Phase
- Phase 4
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals aged 18 and over
- Individuals without any systemic disease
- Individuals without missing teeth
- Individuals who have not used any medication in the last week
- Individuals with normal TMJ MR imaging
- Patients who applied to our clinic and had pain due to temporomandibular disease.
Who cannot join
- Individuals who do not come to their check-ups regularly
- Individuals allergic to any of the study drugs
- Pregnant and lactating individuals
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yuzuncu Yil University, Faculty of Dentistry
Van, Tuşba, 65080
About this study
The most important step in the treatment of TMJ (temporomandibular joint) disease in clinical dentistry is diagnosis and planning. The clinical findings, drug requirement and biological risk of the patients determine the examination methods to be used in the Treatment of Temporomandibular Joint Disorders. In this context, it is thought that studies in the field of dentistry should be increased in order to increase the success in the treatment of TMJ Disorders. The aim of the study is to evaluate the efficacy of of different pain relievers as Dexketoprofen Trometamol + Thiocolchicoside, dexketoprofen trometamol + paracetamol and Dexketoprofen Trometamol in the treatment of pain in TMJ disorders.
Read the detailed description
The study was carried out on 200 patients aged 18 and over, who applied to Van Yuzuncu Yıl University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, with complaints of pain due to temporomandibular disease. When patients first applied to the clinic, their anamnesis were taken and they were directed to MR (Magnetic Resonance) imaging after clinical evaluation. Patients who meet the inclusion criteria and volunteer were included in the study. Patients were randomly divided into 4 groups. Medications were given to patients by auxiliary staff and the study was double-blind. Medicines were given as follows. Dexketoprofen Trometamol + Thiocolchicoside (25mg + 4mg, 2x1) in the 1st group, Dexketoprofen Trometamol + Paracetamol (25mg + 300mg, 2x1) in the 2nd group, only Dexketoprofen Trometamol (25mg, 2x1) in the 3rd group and paracetamol 500 mg in the 4th control group (4x1) were given. In addition, patients in each group used occlusal plate for a minimum of 8 hours per day (at night). Medicines were used regularly for 2 weeks. Paracetamol 500 mg was used only if needed for the next 2 weeks. The pain values of the patients was evaluated with the VAS scale, and the amount of mouth opening was evaluated by measuring the distance between the incisal edges of the lower and upper central teeth. Evaluations have been done at the beginning of the treatment and at the 1st week, 2nd week, 1st month and the 3rd month and the findings were recorded. After the 1st month, the patients were followed up to the 3rd month and the treatment of those who need additional treatment were continued. Obtained data will be analyzed and evaluated statistically.
- Conditions
- Temporomandibular Disorder
- Being tested
- Dexketoprofen Trometamol + Thiocolchicoside, Dexketoprofen Trometamol + Paracetamol, Dexketoprofen Trometamol (25mg), Paracetamol
- 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.
Dexketoprofen Trometamol + ThiocolchicosideDrug
Dexketoprofen Trometamol + Thiocolchicoside (25mg + 4mg) is a NSAID. It was given to the patients twice a day.
Dexketoprofen Trometamol + ParacetamolDrug
Dexketoprofen Trometamol + Paracetamol (25mg + 300mg) is a NSAID. It was given to the patients twice a day.
Dexketoprofen Trometamol (25mg)Drug
Dexketoprofen Trometamol (25mg) is a NSAID. It was given to the patients twice a day.
ParacetamolDrug
Paracetamol (500 mg) is a mild analgesic and antipyretic. It was given to the patients to take only if needed as max. dose 2000mg.
| Study group | Role | What they receive |
|---|---|---|
| Dexketoprofen Trometamol + Thiocolchicoside | Active comparator | (25mg + 4mg, 2x1) Receives: Drug: Dexketoprofen Trometamol + Thiocolchicoside |
| Dexketoprofen Trometamol + Paracetamol | Active comparator | (25mg + 300mg, 2x1) Receives: Drug: Dexketoprofen Trometamol + Paracetamol |
| Dexketoprofen Trometamol | Active comparator | (25mg, 2x1) Receives: Drug: Dexketoprofen Trometamol (25mg) |
| Paracetamol | Active comparator | (500 mg, 4x1) Receives: Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Measured: 1st week
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Measured: 2nd week
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Measured: 1st month
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Measured: 3rd month
Trismus Evaluation
Postoperative trismus will evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
Measured: 1st week
Trismus Evaluation
Postoperative trismus will evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
Measured: 2nd week
Trismus Evaluation
Postoperative trismus will evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
Measured: 1st month
Trismus Evaluation
Postoperative trismus will evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
Measured: 3rd month
Pain Evaluation (at masticatory muscles by palpation)
The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.
Measured: 1st week
Pain Evaluation (at masticatory muscles by palpation)
The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.
Measured: 2nd week
Pain Evaluation (at masticatory muscles by palpation)
The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.
Measured: 1st month
Pain Evaluation (at masticatory muscles by palpation)
The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.
Measured: 3rd month
Clicking-Crepitus Evaluation
Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.
Measured: 1st week
Clicking-Crepitus Evaluation
Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.
Measured: 2nd week
Clicking-Crepitus Evaluation
Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.
Measured: 1st month
Clicking-Crepitus Evaluation
Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.
Measured: 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start16 Jul 2019
- Primary completion15 Jul 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, levent Cigerim, Yuzuncu Yil University
- Investigators
- Levent Ciğerim, Assoc.Prof., Study director, Van Yuzuncu Yil University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529290
- Sponsor's protocol ID
- 03.07.2019/10
- Status last verified
- Aug 2023
- First submitted
- 14 Feb 2022
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Different Drugs in the Treatment of the Pain in Patients With Temporomandibular Disorder
- ClinicalTrials.gov ID
- NCT05529290
- Acronym / sponsor ID
- 03.07.2019/10
- Conditions
- Temporomandibular Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 7 Sep 2022 (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 most important step in the treatment of TMJ (temporomandibular joint) disease in clinical dentistry is diagnosis and planning. The clinical findings, drug requirement and biological risk of the patients determine the examination methods to be used in the Treatment of Temporomandibular Joint Disorders. In this context, it is thought that studies in the field of dentistry should be increased in order to increase the success in the treatment of TMJ Disorders. The aim of the study is to evaluate the efficacy of of different pain relievers as Dexketoprofen Trometamol + Thiocolchicoside, dexketoprofen trometamol + paracetamol and Dexketoprofen Trometamol in the treatment of pain in TMJ disorders.
Detailed description
The study was carried out on 200 patients aged 18 and over, who applied to Van Yuzuncu Yıl University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, with complaints of pain due to temporomandibular disease. When patients first applied to the clinic, their anamnesis were taken and they were directed to MR (Magnetic Resonance) imaging after clinical evaluation. Patients who meet the inclusion criteria and volunteer were included in the study. Patients were randomly divided into 4 groups. Medications were given to patients by auxiliary staff and the study was double-blind. Medicines were given as follows. Dexketoprofen Trometamol + Thiocolchicoside (25mg + 4mg, 2x1) in the 1st group, Dexketoprofen Trometamol + Paracetamol (25mg + 300mg, 2x1) in the 2nd group, only Dexketoprofen Trometamol (25mg, 2x1) in the 3rd group and paracetamol 500 mg in the 4th control group (4x1) were given. In addition, patients in each group used occlusal plate for a minimum of 8 hours per day (at night). Medicines were used regularly for 2 weeks. Paracetamol 500 mg was used only if needed for the next 2 weeks. The pain values of the patients was evaluated with the VAS scale, and the amount of mouth opening was evaluated by measuring the distance between the incisal edges of the lower and upper central teeth. Evaluations have been done at the beginning of the treatment and at the 1st week, 2nd week, 1st month and the 3rd month and the findings were recorded. After the 1st month, the patients were followed up to the 3rd month and the treatment of those who need additional treatment were continued. Obtained data will be analyzed and evaluated statistically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dexketoprofen Trometamol + Thiocolchicoside | Active comparator | Drug: Dexketoprofen Trometamol + Thiocolchicoside(25mg + 4mg, 2x1) |
| Dexketoprofen Trometamol + Paracetamol | Active comparator | Drug: Dexketoprofen Trometamol + Paracetamol(25mg + 300mg, 2x1) |
| Dexketoprofen Trometamol | Active comparator | Drug: Dexketoprofen Trometamol (25mg)(25mg, 2x1) |
| Paracetamol | Active comparator | Drug: Paracetamol(500 mg, 4x1) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Individuals aged 18 and over
- Individuals without any systemic disease
- Individuals without missing teeth
- Individuals who have not used any medication in the last week
- Individuals with normal TMJ MR imaging
Key exclusion criteria (3 listed)
- Individuals who do not come to their check-ups regularly
- Individuals allergic to any of the study drugs
- Pregnant and lactating individuals
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 |
|---|---|---|
| Dexketoprofen Trometamol + ThiocolchicosideDexketoprofen Trometamol + Thiocolchicoside (25mg + 4mg) is a NSAID. It was given to the patients twice a day. | Drug | Dexketoprofen Trometamol + Thiocolchicoside |
| Dexketoprofen Trometamol + ParacetamolDexketoprofen Trometamol + Paracetamol (25mg + 300mg) is a NSAID. It was given to the patients twice a day. | Drug | Dexketoprofen Trometamol + Paracetamol |
| Dexketoprofen Trometamol (25mg)Dexketoprofen Trometamol (25mg) is a NSAID. It was given to the patients twice a day. | Drug | Dexketoprofen Trometamol |
| ParacetamolParacetamol (500 mg) is a mild analgesic and antipyretic. It was given to the patients to take only if needed as max. dose 2000mg. | Drug | Paracetamol |
Primary outcome
Pain Evaluation
Time frame: 1st week
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Pain Evaluation
Time frame: 2nd week
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Pain Evaluation
Time frame: 1st month
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Pain Evaluation
Time frame: 3rd month
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Trismus Evaluation
Time frame: 1st week
Postoperative trismus will evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
Trismus Evaluation
Time frame: 2nd week
Postoperative trismus will evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
Trismus Evaluation
Time frame: 1st month
Postoperative trismus will evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
Trismus Evaluation
Time frame: 3rd month
Postoperative trismus will evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
Pain Evaluation (at masticatory muscles by palpation)
Time frame: 1st week
The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.
Pain Evaluation (at masticatory muscles by palpation)
Time frame: 2nd week
The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.
Pain Evaluation (at masticatory muscles by palpation)
Time frame: 1st month
The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.
Pain Evaluation (at masticatory muscles by palpation)
Time frame: 3rd month
The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.
Clicking-Crepitus Evaluation
Time frame: 1st week
Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.
Clicking-Crepitus Evaluation
Time frame: 2nd week
Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.
Clicking-Crepitus Evaluation
Time frame: 1st month
Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.
Clicking-Crepitus Evaluation
Time frame: 3rd month
Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.
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 22 Aug 2023.
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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.
Levent Ciğerim, Assoc.Prof. study director
Van Yuzuncu Yil University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexketoprofen Trometamol + Thiocolchicoside, Dexketoprofen Trometamol + Paracetamol and Dexketoprofen Trometamol (25mg) in people with Temporomandibular 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 6 inclusion and 3 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 22 Aug 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain Evaluation (time frame: 1st week). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.