Efficacy of Naproxen-codeine, Naproxen+Dexamethasone, and Naproxen on Myofascial Pain
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04066426 |
Recruitment Status :
Completed
First Posted : August 26, 2019
Results First Posted : February 15, 2021
Last Update Posted : February 15, 2021
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Temporomandibular Disorder | Drug: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol | Phase 4 |
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 |
- Pain Evaluation [ Time Frame: Pre-treatment (baseline) ]Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain)
- Pain Evaluation [ Time Frame: At the first week ]Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).
- Pain Evaluation [ Time Frame: At the second week ]Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).
- Pain Evaluation [ Time Frame: At the first month ]Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 69 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Turkey | |
Van Yuzuncu Yil University, Faculty of Dentistry | |
Van, Tuşba, Turkey, 65080 |
Study Chair: | Volkan KAPLAN, PhD | Faculty of dentistry |
Documents provided by levent Cigerim, Yuzuncu Yıl University:
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 |
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 |
naproxen sodium codeine phosphate dexamethasone pain temporomandibular joint |
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 |