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

January 26, 2021 updated by: levent Cigerim, Yuzuncu Yıl University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: naproxen sodium+codeine phosphate
Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Codeine phosphate is an opioid analgesic which has similar applications to those of morphine. However, it is significantly less potent as an analgesic and has only mild sedative effects. The drug's principal site of action is at the µ-opioid receptors (MOR) which are distributed in the central nervous system. Peak effect is reached within 2 hours and analgesic action continues for approximately 4 hours. Naproxen sodium (550 mg)+codeine phosphate (30 mg) was used twice daily in this study.
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.
Other Names:
  • Anaprox Double Strength (DS) + Codeine, Anaprox DS + Decadron, Anaprox DS, Parmol
Experimental: naproxen sodium+dexamethasone
Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily + dexamethasone (8 mg) was used once daily in this study.
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.
Other Names:
  • Anaprox Double Strength (DS) + Codeine, Anaprox DS + Decadron, Anaprox DS, Parmol
Experimental: naproxen sodium
Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily in this study.
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.
Other Names:
  • Anaprox Double Strength (DS) + Codeine, Anaprox DS + Decadron, Anaprox DS, Parmol
Active Comparator: paracetamol
Paracetamol is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, toothache, neuralgia, colds and influenza, sore throat, backache, rheumatic pain and dysmenorrhoea.
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.
Other Names:
  • Anaprox Double Strength (DS) + Codeine, Anaprox DS + Decadron, Anaprox DS, Parmol

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yıl University

Investigators

  • Study Chair: Volkan KAPLAN, PhD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

July 15, 2019

Study Registration Dates

First Submitted

August 17, 2019

First Submitted That Met QC Criteria

August 22, 2019

First Posted (Actual)

August 26, 2019

Study Record Updates

Last Update Posted (Actual)

February 15, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16.02.2018/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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