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

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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:
Information provided by (Responsible Party):
levent Cigerim, Yuzuncu Yıl University

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

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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


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




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).



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066426


Locations
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Turkey
Van Yuzuncu Yil University, Faculty of Dentistry
Van, Tuşba, Turkey, 65080
Sponsors and Collaborators
Yuzuncu Yıl University
Investigators
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Study Chair: Volkan KAPLAN, PhD Faculty of dentistry
  Study Documents (Full-Text)

Documents provided by levent Cigerim, Yuzuncu Yıl University:
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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    Key Record Dates
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

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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:
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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