Efficacy of Naproxen-codeine, Naproxen+Dexamethasone, and Naproxen on Myofascial Pain

Temporomandibular Disorder Clinical Trial

Official title:

Analgesic Efficacy of Naproxen-codeine, Naproxen+Dexamethasone, and Naproxen on Myofascial Pain: A Randomized Double-blind Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04066426
• Other study ID #: 16.02.2018/12
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2018
• Est. completion date: July 15, 2019

Study information

• Verified date: January 2021
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Temporomandibular disorders (TMDs) are one of the most common muco-skeletal disorders, seen in the dental clinics. Many factors work together to initiate or aggravate the condition, so it is a multifactorial disorder. The etiology of TMDs may be a result of parafunctional habits such as clenching and bruxism, acute trauma to the jaw, trauma from hyperextension e.g. after a long dental treatment, joint laxity, psychological distress, occlusal disharmony like presence of high crown or free-end saddle leading to joint instability or systemic diseases such as Rheumatoid arthritis or Osteoarthritis. The aim of this study was to evaluate the effects of naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, and naproxen sodium on pain in patients complaining from temporomandibular pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 15, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• Without a systemic disease,

• Not used any medication in the last week

• Have a habit of clenching and / or grinding teeth, individuals with normal preoperative results, suffering with pain and / or limitation of the mouth opening in the temporomandibular region

Exclusion Criteria:

Individuals who smoke

• Have a parafunctional habits (except for squeezing and grinding teeth)

• Pregnant and breastfeeding individuals

• Allergies to study medicines

• Do not use their medications / use different drugs and non-follow-up

Related Conditions & MeSH terms

• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Drug:
• naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol
NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.

Locations

Country	Name	City	State
Turkey	Van Yuzuncu Yil University, Faculty of Dentistry	Van	Tusba

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Evaluation	Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain)	Pre-treatment (baseline)
Primary	Pain Evaluation	Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).	At the first week
Primary	Pain Evaluation	Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).	At the second week
Primary	Pain Evaluation	Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).	At the first month