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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| naproxen sodium+codeine phosphate | Experimental | 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+dexamethasone | Experimental | 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 | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Evaluation | Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain) | Pre-treatment (baseline) |
| Pain Evaluation | Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain). | At the first week |
| Pain Evaluation | Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain). | At the second week |
| Pain Evaluation | Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain). | At the first month |
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Inclusion Criteria:
Exclusion Criteria:
Individuals who smoke
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| Name | Affiliation | Role |
|---|---|---|
| Volkan KAPLAN, PhD | Cairo University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Van Yuzuncu Yil University, Faculty of Dentistry | Van | Tuşba | 65080 | Turkey (Türkiye) |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| FG002 | 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. 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. |
| FG003 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Thirty-one patients were excluded from the study due to 26 patients having been lost to follow-up, 2 patients used different medication, and 3 patients did not comply with the intended drug dosage. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Evaluation | Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain) | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment (baseline) |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Volkan Kaplan | Tekirdag Namik Kemal University | +90282250000 | 6307 | dr.volkankaplan61@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 17, 2019 | Jan 26, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| D000082 | Acetaminophen |
| D003061 | Codeine |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
| paracetamol | Active Comparator | 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. |
|
|
| BG001 | 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. 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. |
| BG002 | 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. 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. |
| BG003 | 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. 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. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Thirty-one patients were excluded from the study due to 26 patients having been lost to follow-up, 2 patients used different medication, and 3 patients did not comply with the intended drug dosage. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | 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. 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. |
| OG002 | 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. 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. |
| OG003 | 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. 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. |
|
|
| Primary | Pain Evaluation | Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain). | Posted | Mean | Standard Deviation | score on a scale | At the first week |
|
|
|
| Primary | Pain Evaluation | Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain). | Posted | Mean | Standard Deviation | score on a scale | At the second week |
|
|
|
| Primary | Pain Evaluation | Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain). | Posted | Mean | Standard Deviation | score on a scale | At the first month |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | 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. 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. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG002 | 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. 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. | 0 | 42 | 0 | 42 | 0 | 42 |
| EG003 | 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. 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. | 0 | 47 | 0 | 47 | 0 | 47 |
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| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| Male |
|