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NCT Number: NCT05529290

Evaluation of the Efficacy of Different Drugs in the Treatment of the Pain in Patients With Temporomandibular Disorder

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.

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Key information

Conditions

Temporomandibular Disorder Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Van Yuzuncu Yil University, Faculty of Dentistry

Van, Tuşba, 65080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Dexketoprofen Trometamol + Thiocolchicoside

Drug

Dexketoprofen Trometamol + Thiocolchicoside (25mg + 4mg) is a NSAID. It was given to the patients twice a day.

Dexketoprofen Trometamol + Paracetamol

Drug

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.

Paracetamol

Drug

Paracetamol (500 mg) is a mild analgesic and antipyretic. It was given to the patients to take only if needed as max. dose 2000mg.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Clicking-Crepitus Evaluation

    Time frame: 1st week

    Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.

  14. Clicking-Crepitus Evaluation

    Time frame: 2nd week

    Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.

  15. Clicking-Crepitus Evaluation

    Time frame: 1st month

    Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.

  16. Clicking-Crepitus Evaluation

    Time frame: 3rd month

    Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Sep 7, 2022
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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