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Completed

NCT Number: NCT04066426

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

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.

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Key information

Conditions

Temporomandibular Disorder Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Van Yuzuncu Yil University, Faculty of Dentistry

Van, Tuşba, 65080, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol

Drug

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

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 26, 2019
Registry last updated
Feb 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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