Effectiveness of Chlorzoxazone Versus Orphenadrine Citrate in Alleviating Bruxism Pain

Not Applicable

Recruiting

• Conditions: Orofacial Pain; Bruxism
• Interventions: Drug: Chlorzoxazone; Drug: Orphenadrine Citrate

• Registration Number: NCT07109882
• Lead Sponsor: University of Baghdad

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-22
• Study First Submitted: 2025-07-22
• Study First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Primary Completion: 2025-08-01
• Study First Posted: 2025-08-07
• Last Update Posted: 2025-08-07
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorzoxazone Group	Chlorzoxazone	Using Chlorzoxazone
Orphenadrine Citrate group	Orphenadrine Citrate	-

Primary Outcome Measures

Name	Time	Method
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.	From enrollment to the end of treatment at 2 weeks

Trial Locations

Locations (1)

College of Dentistry; 🇮🇶 Baghdad, Iraq