Clinical trial NCT05529290: Evaluation of the Efficacy of Different Drugs in the Treatment of the Pain in Patients With Temporomandibular Disorder
Official title: Evaluation of the Efficacy of Different Drugs in the Treatment of the Pain in Patients With Temporomandibular Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Temporomandibular Disorder
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Individuals aged 18 and over
2. Individuals without any systemic disease
3. Individuals without missing teeth
4. Individuals who have not used any medication in the last week
5. Individuals with normal TMJ MR imaging
6. Patients who applied to our clinic and had pain due to temporomandibular disease.

Exclusion Criteria:

1. Individuals who do not come to their check-ups regularly
2. Individuals allergic to any of the study drugs
3. Pregnant and lactating individuals

Primary outcomes:
measure: Pain Evaluation
timeFrame: 1st week
measure: Pain Evaluation
timeFrame: 2nd week
measure: Pain Evaluation
timeFrame: 1st month
measure: Pain Evaluation
timeFrame: 3rd month
measure: Trismus Evaluation
timeFrame: 1st week
measure: Trismus Evaluation
timeFrame: 2nd week
measure: Trismus Evaluation
timeFrame: 1st month
measure: Trismus Evaluation
timeFrame: 3rd month
measure: Pain Evaluation (at masticatory muscles by palpation)
timeFrame: 1st week
measure: Pain Evaluation (at masticatory muscles by palpation)
timeFrame: 2nd week
measure: Pain Evaluation (at masticatory muscles by palpation)
timeFrame: 1st month
measure: Pain Evaluation (at masticatory muscles by palpation)
timeFrame: 3rd month
measure: Clicking-Crepitus Evaluation
timeFrame: 1st week
measure: Clicking-Crepitus Evaluation
timeFrame: 2nd week
measure: Clicking-Crepitus Evaluation
timeFrame: 1st month
measure: Clicking-Crepitus Evaluation
timeFrame: 3rd month
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Yuzuncu Yil University, Faculty of Dentistry
state: Tuşba
Study officials:
affiliation: Van Yuzuncu Yil University, Faculty of Dentistry
name: Levent Ciğerim, Assoc.Prof.
role: STUDY_DIRECTOR
References: