Chlorzoxazone versus orphenadrine citrate for relieving bruxism-related jaw and facial pain
Clinical Effectiveness of Chlorzoxazone Versus Orphenadrine Citrate in Alleviating Bruxism- Related Orofacial Pain: A Randomized Clinical Trial
PHASE4 · University of Baghdad · NCT07109882
This trial will test whether chlorzoxazone or orphenadrine citrate better reduces jaw and facial pain in people who grind their teeth (bruxism).
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | University of Baghdad (other) |
| Locations | 1 site (Baghdad) |
| Trial ID | NCT07109882 on ClinicalTrials.gov |
What this trial studies
This randomized, interventional Phase 4 trial will enroll 60 patients older than 15 with orofacial and temporomandibular pain and no chronic systemic illness. Participants will be randomly assigned to receive either chlorzoxazone (Relaxon) or orphenadrine citrate (Norgesic) twice daily for two weeks. Pain will be measured using a visual analogue scale at baseline, day 7, and day 14, and temporomandibular joint function will be evaluated at baseline and day 14. Results will be analyzed using nonparametric statistics in SPSS v29 to compare short-term pain and TMJ parameter changes between groups.
Who should consider this trial
Good fit: Ideal candidates are people older than 15 with bruxism-related orofacial/TMJ pain who have no chronic systemic illnesses and are not taking analgesics.
Not a fit: Patients with recent orofacial or head injuries, those with chronic systemic illness, or those who have taken analgesics in the prior 14 days are unlikely to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, the results could identify which commonly available muscle relaxant provides better short-term relief of bruxism-related orofacial pain.
How similar studies have performed: Muscle relaxants have been used for orofacial muscle pain, but direct head-to-head comparisons for bruxism are limited, so this specific comparison is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged above 15 years-old complaining of orofacial and temporomandibular disorder/pain. * Patients with no history of chronic systemic illness. Exclusion Criteria: * Patients with orofacial injuries. * Patients with head injuries. * Patients Taking analgesics for the last 14 days.
Where this trial is running
Baghdad
- College of Dentistry — Baghdad, Iraq (RECRUITING)
Study contacts
- Study coordinator: Noor R. Al-Hasani, PhD
- Email: noor.raouf@codental.uobaghdad.edu.iq
- Phone: 009647732977290
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Orofacial Pain, Bruxism