NCT05529290

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2019

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

February 14, 2022

Last Update Submit

August 20, 2023

Conditions

Temporomandibular Disorder

Outcome Measures

Primary Outcomes (16)

  • 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

Study Arms (4)

Dexketoprofen Trometamol + Thiocolchicoside

ACTIVE COMPARATOR

(25mg + 4mg, 2x1)

Drug: Dexketoprofen Trometamol + Thiocolchicoside

Dexketoprofen Trometamol + Paracetamol

ACTIVE COMPARATOR

(25mg + 300mg, 2x1)

Drug: Dexketoprofen Trometamol + Paracetamol

Dexketoprofen Trometamol

ACTIVE COMPARATOR

(25mg, 2x1)

Drug: Dexketoprofen Trometamol (25mg)

Paracetamol

ACTIVE COMPARATOR

(500 mg, 4x1)

Drug: Paracetamol

Interventions

Dexketoprofen Trometamol + ThiocolchicosideDRUG

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

Dexketoprofen Trometamol + Thiocolchicoside
Dexketoprofen Trometamol + ParacetamolDRUG

Dexketoprofen Trometamol + Paracetamol (25mg + 300mg) is a NSAID. It was given to the patients twice a day.

Dexketoprofen Trometamol + Paracetamol
Dexketoprofen Trometamol (25mg)DRUG

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

Dexketoprofen Trometamol
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.

Paracetamol

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yuzuncu Yil University, Faculty of Dentistry

Van, Tuşba, 65080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

dexketoprofen trometamolthiocolchicosideAcetaminophen

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Levent Ciğerim, Assoc.Prof.

    Van Yuzuncu Yil University, Faculty of Dentistry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Oral and Maxillofacial Surgery Department

Study Record Dates

First Submitted

February 14, 2022

First Posted

September 7, 2022

Study Start

July 16, 2019

Primary Completion

July 15, 2021

Study Completion

February 1, 2022

Last Updated

August 22, 2023

Record last verified: 2023-08

Locations

TU(1)