MedTrace Logo

Evaluation of BTX Injections in Treatment of Bruxism

NCT05980559 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-01-05

No results posted yet for this study

Summary

Aim of this study is to evaluate the effect of botulinum toxin type A (Xeomin®) on patients complaining from bruxism.

The study will be a one arm clinical trial. Twelve subjects reporting bruxism irresponsive to conventional treatment modalities will be recruited and will be injected with botulinum toxin A (Xeomin®) in both masseter and temporalis muscles. Pain levels, Electromyographic activity and maximum occlusal force will be recorded in the subjects before injection and at 1 and 3 months after injection to determine the effect of treatment

Conditions

  • Bruxism

Interventions

DRUG

Xeomin

50 units of Incobotulinumtoxin A (BTX A) Xeomin® Injections into the masseter and temporalis muscles bilaterally (15 Units per muscle applied with 2 injections in each masseter muscle) (10 Units per muscle applied with 2 injections in each temporalis muscle)

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • Ragab S. Hassan, Professor · Alexandria University

  • Gaafar N. Elhalawani, Lecturer · Alexandria University

  • Walaa A. Elwakil, Lecturer · University of Alexandria

  • Marwa M. Mancy, Bachelors · Alexandria University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2024-01-15
Completion
2024-04-15

More Related Trials

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 NCT05980559 on ClinicalTrials.gov