Evaluation of the Efficacy of Different Drugs in the Treatment of the Pain in Patients With Temporomandibular Disorder
Primary Purpose
Temporomandibular Disorder
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Dexketoprofen Trometamol + Thiocolchicoside
Dexketoprofen Trometamol + Paracetamol
Dexketoprofen Trometamol (25mg)
Paracetamol
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Disorder
Eligibility Criteria
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
Sites / Locations
- Van Yuzuncu Yil University, Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Dexketoprofen Trometamol + Thiocolchicoside
Dexketoprofen Trometamol + Paracetamol
Dexketoprofen Trometamol
Paracetamol
Arm Description
(25mg + 4mg, 2x1)
(25mg + 300mg, 2x1)
(25mg, 2x1)
(500 mg, 4x1)
Outcomes
Primary Outcome Measures
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).
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).
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).
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).
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.
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.
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.
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.
Pain Evaluation (at masticatory muscles by palpation)
The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.
Pain Evaluation (at masticatory muscles by palpation)
The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.
Pain Evaluation (at masticatory muscles by palpation)
The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.
Pain Evaluation (at masticatory muscles by palpation)
The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.
Clicking-Crepitus Evaluation
Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.
Clicking-Crepitus Evaluation
Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.
Clicking-Crepitus Evaluation
Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.
Clicking-Crepitus Evaluation
Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.
Secondary Outcome Measures
Full Information
NCT ID
NCT05529290
First Posted
February 14, 2022
Last Updated
August 20, 2023
Sponsor
Yuzuncu Yıl University
1. Study Identification
Unique Protocol Identification Number
NCT05529290
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 16, 2019 (Actual)
Primary Completion Date
July 15, 2021 (Actual)
Study Completion Date
February 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexketoprofen Trometamol + Thiocolchicoside
Arm Type
Active Comparator
Arm Description
(25mg + 4mg, 2x1)
Arm Title
Dexketoprofen Trometamol + Paracetamol
Arm Type
Active Comparator
Arm Description
(25mg + 300mg, 2x1)
Arm Title
Dexketoprofen Trometamol
Arm Type
Active Comparator
Arm Description
(25mg, 2x1)
Arm Title
Paracetamol
Arm Type
Active Comparator
Arm Description
(500 mg, 4x1)
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen Trometamol + Thiocolchicoside
Intervention Description
Dexketoprofen Trometamol + Thiocolchicoside (25mg + 4mg) is a NSAID. It was given to the patients twice a day.
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen Trometamol + Paracetamol
Intervention Description
Dexketoprofen Trometamol + Paracetamol (25mg + 300mg) is a NSAID. It was given to the patients twice a day.
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen Trometamol (25mg)
Intervention Description
Dexketoprofen Trometamol (25mg) is a NSAID. It was given to the patients twice a day.
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Intervention Description
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 Outcome Measure Information:
Title
Pain Evaluation
Description
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).
Time Frame
1st week
Title
Pain Evaluation
Description
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).
Time Frame
2nd week
Title
Pain Evaluation
Description
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).
Time Frame
1st month
Title
Pain Evaluation
Description
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).
Time Frame
3rd month
Title
Trismus Evaluation
Description
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.
Time Frame
1st week
Title
Trismus Evaluation
Description
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.
Time Frame
2nd week
Title
Trismus Evaluation
Description
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.
Time Frame
1st month
Title
Trismus Evaluation
Description
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.
Time Frame
3rd month
Title
Pain Evaluation (at masticatory muscles by palpation)
Description
The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.
Time Frame
1st week
Title
Pain Evaluation (at masticatory muscles by palpation)
Description
The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.
Time Frame
2nd week
Title
Pain Evaluation (at masticatory muscles by palpation)
Description
The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.
Time Frame
1st month
Title
Pain Evaluation (at masticatory muscles by palpation)
Description
The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.
Time Frame
3rd month
Title
Clicking-Crepitus Evaluation
Description
Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.
Time Frame
1st week
Title
Clicking-Crepitus Evaluation
Description
Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.
Time Frame
2nd week
Title
Clicking-Crepitus Evaluation
Description
Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.
Time Frame
1st month
Title
Clicking-Crepitus Evaluation
Description
Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.
Time Frame
3rd month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Levent Ciğerim, Assoc.Prof.
Organizational Affiliation
Van Yuzuncu Yil University, Faculty of Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Van Yuzuncu Yil University, Faculty of Dentistry
City
Van
State/Province
Tuşba
ZIP/Postal Code
65080
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Efficacy of Different Drugs in the Treatment of the Pain in Patients With Temporomandibular Disorder
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