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.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Disorder
• Intervention / Treatment: Drug: Dexketoprofen Trometamol + Thiocolchicoside; Drug: Dexketoprofen Trometamol + Paracetamol; Drug: Dexketoprofen Trometamol (25mg); Drug: Paracetamol

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Tuşba
    • Van, Tuşba, Turkey, 65080
      • Van Yuzuncu Yil University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexketoprofen Trometamol + Thiocolchicoside; (25mg + 4mg, 2x1)	Drug: Dexketoprofen Trometamol + Thiocolchicoside; Dexketoprofen Trometamol + Thiocolchicoside (25mg + 4mg) is a NSAID. It was given to the patients twice a day.
Active Comparator: Dexketoprofen Trometamol + Paracetamol; (25mg + 300mg, 2x1)	Drug: Dexketoprofen Trometamol + Paracetamol; Dexketoprofen Trometamol + Paracetamol (25mg + 300mg) is a NSAID. It was given to the patients twice a day.
Active Comparator: Dexketoprofen Trometamol; (25mg, 2x1)	Drug: Dexketoprofen Trometamol (25mg); Dexketoprofen Trometamol (25mg) is a NSAID. It was given to the patients twice a day.
Active Comparator: Paracetamol; (500 mg, 4x1)	Drug: Paracetamol; Paracetamol (500 mg) is a mild analgesic and antipyretic. It was given to the patients to take only if needed as max. dose 2000mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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.	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.	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.	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.	3rd month
Pain Evaluation (at masticatory muscles by palpation)	The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.	1st week
Pain Evaluation (at masticatory muscles by palpation)	The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.	2nd week
Pain Evaluation (at masticatory muscles by palpation)	The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.	1st month
Pain Evaluation (at masticatory muscles by palpation)	The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.	3rd month
Clicking-Crepitus Evaluation	Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.	1st week
Clicking-Crepitus Evaluation	Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.	2nd week
Clicking-Crepitus Evaluation	Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.	1st month
Clicking-Crepitus Evaluation	Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.	3rd month

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University
• Investigators: Study Director: Levent Ciğerim, Assoc.Prof., Van Yuzuncu Yil University, Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2019
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 20, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ketoprofen; Dexketoprofen trometamol
• Other Study ID Numbers: 03.07.2019/10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No