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

• Sponsor: Yuzuncu Yıl University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04066426
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 4
• Actual Duration (Months): 16.5
• Patients Per Site Per Month: 12.2

Study Details

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
• 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: Mar 1, 2018
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Jul 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 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

Outcome Measures

Primary Outcome Measures

1. Pain Evaluation [Pre-treatment (baseline)]

   Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain)

2. Pain Evaluation [At the first week]

   Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).

3. Pain Evaluation [At the second week]

   Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).

4. Pain Evaluation [At the first month]

   Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 69 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Van Yuzuncu Yil University, Faculty of Dentistry	Van	Tuşba	Turkey	65080

Sponsors and Collaborators

• Yuzuncu Yıl University

Investigators

• Study Chair: Volkan KAPLAN, PhD, Cairo University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 17, 2019

More Information

Publications

None provided.

• 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: Aug 26, 2019
• Last Update Posted: Feb 15, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• 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, Head of Oral and Maxillofacial Surgery Department, Yuzuncu Yıl University: naproxen sodium; codeine phosphate; dexamethasone; pain; temporomandibular joint
• Additional relevant MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Acetaminophen; Dexamethasone; Naproxen; Codeine

Study Results

Participant Flow

Arm/Group Title	Naproxen Sodium+Codeine Phosphate	Naproxen Sodium+Dexamethasone	Naproxen Sodium	Paracetamol
Arm/Group Description	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. 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.	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. 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.	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. 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.	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. 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.
Period Title: Overall Study
STARTED	50	50	50	50
COMPLETED	40	40	42	47
NOT COMPLETED	10	10	8	3

Baseline Characteristics

Arm/Group Title	Naproxen Sodium+Codeine Phosphate	Naproxen Sodium+Dexamethasone	Naproxen Sodium	Paracetamol	Total
Arm/Group Description	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. 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.	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. 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.	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. 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.	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. 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.	Total of all reporting groups
Overall Participants	50	50	50	50	200
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.18 (10.06)	27.15 (10.86)	29.38 (11.72)	25.60 (9.57)	27.04 (10.56)
Sex: Female, Male (Count of Participants)
Female	33 66%	28 56%	36 72%	35 70%	132 66%
Male	7 14%	12 24%	6 12%	12 24%	37 18.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Pain Evaluation
Description	Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain)
Time Frame	Pre-treatment (baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naproxen Sodium+Codeine Phosphate	Naproxen Sodium+Dexamethasone	Naproxen Sodium	Paracetamol
Arm/Group Description	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. 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.	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. 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.	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. 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.	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. 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.
Measure Participants	40	40	42	47
Mean (Standard Deviation) [score on a scale]	6.38 (1.86)	6.93 (1.76)	5.76 (2.74)	5.49 (2.73)

2. Primary Outcome

Title	Pain Evaluation
Description	Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).
Time Frame	At the first week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naproxen Sodium+Codeine Phosphate	Naproxen Sodium+Dexamethasone	Naproxen Sodium	Paracetamol
Arm/Group Description	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. 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.	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. 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.	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. 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.	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. 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.
Measure Participants	40	40	42	47
Mean (Standard Deviation) [score on a scale]	4.68 (1.82)	5.93 (2.22)	4.95 (2.85)	4.60 (2.89)

3. Primary Outcome

Title	Pain Evaluation
Description	Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).
Time Frame	At the second week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naproxen Sodium+Codeine Phosphate	Naproxen Sodium+Dexamethasone	Naproxen Sodium	Paracetamol
Arm/Group Description	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. 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.	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. 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.	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. 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.	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. 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.
Measure Participants	40	40	42	47
Mean (Standard Deviation) [score on a scale]	3.58 (1.69)	5.28 (2.36)	4.33 (2.78)	4.34 (3.03)

4. Primary Outcome

Title	Pain Evaluation
Description	Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).
Time Frame	At the first month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naproxen Sodium+Codeine Phosphate	Naproxen Sodium+Dexamethasone	Naproxen Sodium	Paracetamol
Arm/Group Description	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. 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.	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. 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.	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. 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.	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. 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.
Measure Participants	40	40	42	47
Mean (Standard Deviation) [score on a scale]	2.93 (1.65)	5.28 (2.50)	3.69 (2.71)	4.38 (2.96)

Adverse Events

Time Frame	4 weeks
Arm/Group Title	Naproxen Sodium+Codeine Phosphate		Naproxen Sodium+Dexamethasone		Naproxen Sodium		Paracetamol
Arm/Group Description	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. 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.		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. 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.		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. 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.		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. 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.
All Cause Mortality
	Naproxen Sodium+Codeine Phosphate		Naproxen Sodium+Dexamethasone		Naproxen Sodium		Paracetamol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)		0/42 (0%)		0/47 (0%)
Serious Adverse Events
	Naproxen Sodium+Codeine Phosphate		Naproxen Sodium+Dexamethasone		Naproxen Sodium		Paracetamol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)		0/42 (0%)		0/47 (0%)
Other (Not Including Serious) Adverse Events
	Naproxen Sodium+Codeine Phosphate		Naproxen Sodium+Dexamethasone		Naproxen Sodium		Paracetamol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)		0/42 (0%)		0/47 (0%)

Limitations/Caveats

The diversity of the individuals in the groups was the limitation of this study. Different individual characteristics may change the efficacy of drugs in groups.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.