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Botulinum Toxin A Injectable Solution in the Management of Bruxism: A Clinical Trial Study

NCT03827122 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-02-01

No results posted yet for this study

Summary

A Clinical Trial Study to investigate the potential performance of BTXA on masseter muscle on patient with nocturnal bruxism and to check the pain scale and share this clinical experience.

Conditions

  • Nocturnal Bruxism

Interventions

DRUG

onabotulinumtoxinA

Experimental group we will use BTX-A administration group. All patients (Male/Female) with bruxism associated with chronic pain in masseter muscles bilaterally Patients will have treatment with 20 units of BOTOX, (Allergan Inc.) per side will be injected at three points into masseter muscle bilaterally.

Sponsors & Collaborators

  • Riyadh Colleges of Dentistry and Pharmacy

    lead OTHER

Principal Investigators

  • Baraa abdulrahman, BDS · Riyadh Colleges of Dentistry and Pharmacy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-13
Primary Completion
2019-11-11
Completion
2019-11-13
FDA Drug
Yes

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03827122 on ClinicalTrials.gov