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

• ClinicalTrials.gov Identifier: NCT04066426
• Recruitment Status: Completed
• First Posted: August 26, 2019
• Results First Posted: February 15, 2021
• Last Update Posted: February 15, 2021
• Sponsor: Yuzuncu Yıl University
• Information provided by (Responsible Party): levent Cigerim, Yuzuncu Yıl University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Temporomandibular Disorder	Drug: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Analgesic Efficacy of Naproxen-codeine, Naproxen+Dexamethasone, and Naproxen on Myofascial Pain: A Randomized Double-blind Controlled Trial
• Actual Study Start Date: March 1, 2018
• Actual Primary Completion Date: April 1, 2019
• Actual Study Completion Date: July 15, 2019

Arms and Interventions

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 Name: 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 Name: 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 Name: 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 Name: Anaprox Double Strength (DS) + Codeine, Anaprox DS + Decadron, Anaprox DS, Parmol

Outcome Measures

Primary Outcome Measures :

1. Pain Evaluation [ Time Frame: Pre-treatment (baseline) ]
   Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain)
2. Pain Evaluation [ Time Frame: At the first week ]
   Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).
3. Pain Evaluation [ Time Frame: At the second week ]
   Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).
4. Pain Evaluation [ Time Frame: At the first month ]
   Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 69 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Turkey

Van Yuzuncu Yil University, Faculty of Dentistry

Van, Tuşba, Turkey, 65080

Sponsors and Collaborators

Yuzuncu Yıl University

Investigators

• Study Chair: Volkan KAPLAN, PhD; Faculty of dentistry

  Study Documents (Full-Text)

Documents provided by levent Cigerim, Yuzuncu Yıl University:

Study Protocol and Statistical Analysis Plan  [PDF] August 17, 2019

More Information

• Responsible Party: levent Cigerim, Head of Oral and Maxillofacial Surgery Department, Yuzuncu Yıl University
• ClinicalTrials.gov Identifier: NCT04066426
• Other Study ID Numbers: 16.02.2018/12
• First Posted: August 26, 2019
• Results First Posted: February 15, 2021
• Last Update Posted: February 15, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by levent Cigerim, Yuzuncu Yıl University:

naproxen sodium; codeine phosphate; dexamethasone; pain; temporomandibular joint

Additional relevant MeSH terms:

Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Myofascial Pain Syndromes; Acetaminophen; Dexamethasone; Naproxen; Codeine; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal