Effectiveness of Chlorzoxazone Versus Orphenadrine Citrate in Alleviating Bruxism Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chlorzoxazone, Orphenadrine Citrate.
- Who it may be relevant to
- Registry conditions: Orofacial Pain, Bruxism. Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Iraq
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Effectiveness of Chlorzoxazone Versus Orphenadrine Citrate in Alleviating Bruxism- Related Orofacial Pain: A Randomized Clinical Trial
Overview
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.
Interventions
- Drug Chlorzoxazone
This group will receive Chlorzoxazone twice daily for two weeks - Drug Orphenadrine Citrate
This group will receive Orphenadrine Citrate twice daily for two weeks.
Primary outcome measures
- 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]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Iraq · 1 center
- College of Dentistry — Baghdad
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. PMID 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. PMID 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. PMID 39064299
Identifiers
NCT: NCT07109882 · 1035425