Effectiveness of Chlorzoxazone Versus Orphenadrine Citrate in Alleviating Bruxism Pain
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age15+
SponsorUniversity of Baghdad
About this trial
To evaluate the clinical effectiveness of chlorzoxazone in comparison to orphenadrine Citrate in relieving the orofacial pain in bruxers. Subjects and Methods: 60 patients above 15-years old complaining of orofacial and temporomandibular disorder/pain, with no history of chronic systemic illness, will be recruited. Patients will randomly be allocated into two groups (n=30): the first group will receive Relaxon (chlorzoxazone) twice daily for two weeks, while the second group will receive Norgesic (orphenadrine Citrate) twice daily for two weeks as well. Pain severity will be assessed by Visual Analogue Scale (VAS) at day 0, 7, and day 14. In addition, a temporomandibular joint (TMJ) evaluation form will be utilized to assess the TMJ parameters before and after initiation of the treatment protocol, i.e at 0 and 14 days. Non parametric statistical analysis will be conducted to explain the results using SPSS V29.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients aged above 15 years-old complaining of orofacial and temporomandibular disorder/pain.
Patients with no history of chronic systemic illness.
Disqualifiers
Patients with orofacial injuries.
Patients with head injuries.
Patients Taking analgesics for the last 14 days.
Trial design
Design model
Parallel
Treatments tested in this trial
Chlorzoxazone
DrugThis group will receive Chlorzoxazone twice daily for two weeks
Orphenadrine Citrate
DrugThis group will receive Orphenadrine Citrate twice daily for two weeks.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Chlorzoxazone GroupActive comparator 1 intervention
Group B: Orphenadrine Citrate groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change From Baseline in Orofacial Pain Score in Bruxism Patients (n=30) as Measured by the Visual Analog Scale (VAS) in retaliation to adverse effect of each drug used.
Time frame
From enrollment to the end of treatment at 2 weeksSponsors and contacts
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Source ClinicalTrials.gov