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NCT Number: NCT07109882

Effectiveness of Chlorzoxazone Versus Orphenadrine Citrate in Alleviating Bruxism Pain

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.

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

College of Dentistry

Baghdad, Iraq

Location status: Recruiting

Location contact

Noor Al-Hasni, PhD

CONTACT

0096407732977290

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chlorzoxazone

Drug

This group will receive Chlorzoxazone twice daily for two weeks

Orphenadrine Citrate

Drug

This group will receive Orphenadrine Citrate twice daily for two weeks.

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 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Noor R. Al-Hasani, PhD

CONTACT

[email protected]

009647732977290

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

Clinical Effectiveness of Chlorzoxazone Versus Orphenadrine Citrate in Alleviating Bruxism- Related Orofacial Pain: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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