Phase 4
N=200
Efficacy of Naproxen-codeine, Naproxen+Dexamethasone, and Naproxen on Myofascial Pain
Temporomandibular Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04066426 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Pain Evaluation — 6.38; 6.93; 5.76; 5.49 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yuzuncu Yil University
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Evaluation |
2.93; 5.28; 3.69; 4.38 | — |
| PRIMARY Pain Evaluation |
2.93; 5.28; 3.69; 4.38 | — |
| PRIMARY Pain Evaluation |
2.93; 5.28; 3.69; 4.38 | — |
| PRIMARY Pain Evaluation |
2.93; 5.28; 3.69; 4.38 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04066426). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.