NCT07109882

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 22, 2025

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

10 days

First QC Date

July 22, 2025

Last Update Submit

July 30, 2025

Conditions

Orofacial PainBruxism

Outcome Measures

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.

    From enrollment to the end of treatment at 2 weeks

Study Arms (2)

Chlorzoxazone Group

ACTIVE COMPARATOR

Using Chlorzoxazone

Drug: Chlorzoxazone

Orphenadrine Citrate group

ACTIVE COMPARATOR
Drug: Orphenadrine Citrate

Interventions

ChlorzoxazoneDRUG

This group will receive Chlorzoxazone twice daily for two weeks

Chlorzoxazone Group
Orphenadrine CitrateDRUG

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

Orphenadrine Citrate group

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged above 15 years-old complaining of orofacial and temporomandibular disorder/pain.
  • Patients with no history of chronic systemic illness.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Dentistry

Baghdad, Iraq

RECRUITING

Related Publications (5)

  • 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.

    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.

    BACKGROUND

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

    PMID: 19492540BACKGROUND

  • 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: 33061557BACKGROUND

  • 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: 39064299BACKGROUND

Related Links

MeSH Terms

Conditions

Facial PainBruxism

Interventions

ChlorzoxazoneOrphenadrine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTooth DiseasesStomatognathic DiseasesHabitsBehavior

Intervention Hierarchy (Ancestors)

BenzoxazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsEthylaminesAminesOrganic ChemicalsBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Central Study Contacts

Noor R. Al-Hasani, PhD

CONTACT

009647732977290noor.raouf@codental.uobaghdad.edu.iq

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

July 22, 2025

First Posted

August 7, 2025

Study Start

July 22, 2025

Primary Completion

August 1, 2025

Study Completion

August 30, 2025

Last Updated

August 7, 2025

Record last verified: 2025-07

Locations

IR(1)