Effectiveness of Chlorzoxazone Versus Orphenadrine Citrate in Alleviating Bruxism Pain

NCT ID: NCT07109882

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-22

Study Completion Date

2025-08-30

Brief Summary

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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

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Conditions

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Orofacial Pain Bruxism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Chlorzoxazone Group

Using Chlorzoxazone

Group Type ACTIVE_COMPARATOR

Chlorzoxazone

Intervention Type DRUG

This group will receive Chlorzoxazone twice daily for two weeks

Orphenadrine Citrate group

Group Type ACTIVE_COMPARATOR

Orphenadrine Citrate

Intervention Type DRUG

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

Interventions

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Chlorzoxazone

This group will receive Chlorzoxazone twice daily for two weeks

Intervention Type DRUG

Orphenadrine Citrate

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Baghdad

OTHER

Sponsor Role lead

Responsible Party

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Noor R. Al-Hasani

Asst. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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College of Dentistry

Baghdad, , Iraq

Site Status RECRUITING

Countries

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Iraq

Central Contacts

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Noor R. Al-Hasani, PhD

Role: CONTACT

009647732977290

Facility Contacts

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Noor Al-Hasni, PhD

Role: primary

0096407732977290

References

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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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Manfredini D, Lobbezoo F. Role of psychosocial factors in the etiology of bruxism. J Orofac Pain. 2009 Spring;23(2):153-66.

Reference Type BACKGROUND
PMID: 19492540 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33061557 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39064299 (View on PubMed)

Related Links

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Other Identifiers

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1035425

Identifier Type: -

Identifier Source: org_study_id

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