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RecruitingNCT07109882Updated Aug 7, 2025

Effectiveness of Chlorzoxazone Versus Orphenadrine Citrate in Alleviating Bruxism Pain

A Phase 4 interventional study of Chlorzoxazone and Orphenadrine Citrate in Orofacial Pain and Bruxism, sponsored by University of Baghdad. Recruiting at 1 site in Iraq. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-07.

Sponsored by University of Baghdad · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Jul 2025; still recruiting 1 year 3 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Orofacial Pain
  • Bruxism
03

In context

Facial Pain

182 studies on the registry are indexed under Facial Pain; 61 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 132 interventional studies indexed under Facial Pain.

Browse Facial Pain studies →

Lead sponsor

University of Baghdad is the lead sponsor of 170 studies on the registry; 69 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients with orofacial injuries.
  • Patients with head injuries.
  • Patients Taking analgesics for the last 14 days.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Chlorzoxazone Group

    Using Chlorzoxazone

    Drug: Chlorzoxazone

  • Active comparator
    Orphenadrine Citrate group

    Drug: Orphenadrine Citrate

Interventions

  • This group will receive Chlorzoxazone twice daily for two weeks

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Al-Ameri LT, Issa SB, Abd Marzook A, Hameed EK, Jasem NH. Efficacy of Chlorzoxazone versus Orphenadrine in the management of pain associated with cervical spondylosis. Rawal Medical Journal. 2018;43:488-490.
  • ElBohy D, Ateyya H, Elkot SM. Dentist & pharmacist communication awareness about skeletal muscle relaxants; survey in Egypt. Archives of Pharmaceutical Sciences Ain Shams University. 2023;7:240-253.
  • Manfredini D, Lobbezoo F. Role of psychosocial factors in the etiology of bruxism. J Orofac Pain. 2009 Spring;23(2):153-66. PubMed 19492540 ↗
  • Bussadori SK, Motta LJ, Horliana ACRT, Santos EM, Martimbianco ALC. The Current Trend in Management of Bruxism and Chronic Pain: An Overview of Systematic Reviews. J Pain Res. 2020 Sep 30;13:2413-2421. doi: 10.2147/JPR.S268114. eCollection 2020. PubMed 33061557 ↗
  • Zielinski G, Pajak A, Wojcicki M. Global Prevalence of Sleep Bruxism and Awake Bruxism in Pediatric and Adult Populations: A Systematic Review and Meta-Analysis. J Clin Med. 2024 Jul 22;13(14):4259. doi: 10.3390/jcm13144259. PubMed 39064299 ↗

Related links

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07109882
Responsible party
Noor R. Al-Hasani (Asst. Prof. Dr., University of Baghdad) — Principal investigator
First posted
Aug 7, 2025
Start date
Jul 22, 2025
Primary completion
Aug 1, 2025 (estimated)
Completion
Aug 30, 2025 (estimated)
Last update
Aug 7, 2025

Study contacts

Noor R. Al-Hasani, PhD
Contact
noor.raouf@codental.uobaghdad.edu.iq
009647732977290

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Chlorzoxazone · Orphenadrine

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