Temporomandibular Disorder
Conditions
Keywords
naproxen sodium, codeine phosphate, dexamethasone, pain, temporomandibular joint
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.
Interventions
DRUGnaproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol
NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Sponsors
Yuzuncu Yil University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Evaluation | Pre-treatment (baseline) | Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain) |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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. | 50 |
| 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. | 50 |
| 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. | 50 |
| Total | 200 |
Baseline characteristics
| Characteristic | Naproxen Sodium+Codeine Phosphate | Naproxen Sodium+Dexamethasone | Naproxen Sodium | Paracetamol | Total |
|---|---|---|---|---|---|
| Age, Continuous | 26.18 years STANDARD_DEVIATION 10.06 | 27.15 years STANDARD_DEVIATION 10.86 | 29.38 years STANDARD_DEVIATION 11.72 | 25.60 years STANDARD_DEVIATION 9.57 | 27.04 years STANDARD_DEVIATION 10.56 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 33 Participants | 28 Participants | 36 Participants | 35 Participants | 132 Participants |
| Sex: Female, Male Male | 7 Participants | 12 Participants | 6 Participants | 12 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 | 0 / 42 | 0 / 47 |
| other Total, other adverse events | 0 / 40 | 0 / 40 | 0 / 42 | 0 / 47 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 42 | 0 / 47 |
Outcome results
Primary
Pain Evaluation
Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain)
Time frame: Pre-treatment (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naproxen Sodium+Codeine Phosphate | Pain Evaluation | 6.38 score on a scale | Standard Deviation 1.86 |
| Naproxen Sodium+Dexamethasone | Pain Evaluation | 6.93 score on a scale | Standard Deviation 1.76 |
| Naproxen Sodium | Pain Evaluation | 5.76 score on a scale | Standard Deviation 2.74 |
| Paracetamol | Pain Evaluation | 5.49 score on a scale | Standard Deviation 2.73 |
Primary
Pain Evaluation
Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).
Time frame: At the first week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naproxen Sodium+Codeine Phosphate | Pain Evaluation | 4.68 score on a scale | Standard Deviation 1.82 |
| Naproxen Sodium+Dexamethasone | Pain Evaluation | 5.93 score on a scale | Standard Deviation 2.22 |
| Naproxen Sodium | Pain Evaluation | 4.95 score on a scale | Standard Deviation 2.85 |
| Paracetamol | Pain Evaluation | 4.60 score on a scale | Standard Deviation 2.89 |
Primary
Pain Evaluation
Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).
Time frame: At the second week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naproxen Sodium+Codeine Phosphate | Pain Evaluation | 3.58 score on a scale | Standard Deviation 1.69 |
| Naproxen Sodium+Dexamethasone | Pain Evaluation | 5.28 score on a scale | Standard Deviation 2.36 |
| Naproxen Sodium | Pain Evaluation | 4.33 score on a scale | Standard Deviation 2.78 |
| Paracetamol | Pain Evaluation | 4.34 score on a scale | Standard Deviation 3.03 |
Primary
Pain Evaluation
Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).
Time frame: At the first month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naproxen Sodium+Codeine Phosphate | Pain Evaluation | 2.93 score on a scale | Standard Deviation 1.65 |
| Naproxen Sodium+Dexamethasone | Pain Evaluation | 5.28 score on a scale | Standard Deviation 2.5 |
| Naproxen Sodium | Pain Evaluation | 3.69 score on a scale | Standard Deviation 2.71 |
| Paracetamol | Pain Evaluation | 4.38 score on a scale | Standard Deviation 2.96 |