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Search / Trial NCT05980559

Evaluation of BTX Injections in Treatment of Bruxism

Launched by ALEXANDRIA UNIVERSITY · Aug 4, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Botulinum Toxin Electromyographic Occlusense

ClinConnect Summary

This clinical trial is studying the use of injections of a medication called botulinum toxin type A (Xeomin®) to help people who suffer from bruxism, which is the involuntary grinding or clenching of teeth. The goal is to see if this treatment can reduce pain and muscle activity in the jaw for individuals who have not found relief from traditional treatments like pain relievers, physical therapy, or dental devices. The study will involve 12 participants between the ages of 20 and 60 who experience pain in their jaw muscles due to bruxism and have never had botulinum toxin injections before.

If you qualify for the trial, you will receive injections in specific jaw muscles and then be monitored for any changes in pain levels and muscle activity at 1 and 3 months after the treatment. It’s important to know that this trial is not open for recruitment yet, and certain individuals, such as pregnant or breastfeeding women and those with specific neurological conditions, will not be eligible to participate. This study aims to find a new way to help those who struggle with bruxism and may provide valuable information for future treatments.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Patient between 20 and 60 years of age.
  • 2. Pain related to the masseter muscles and TMJ area due to bruxism.
  • 3. Patient who has never received botulinum toxins.
  • 4. Patient who did not respond to the conventional treatments (analgesic, physiotherapy, relaxation technique and maxillary retainer).
  • Exclusion Criteria:
  • 1. Pregnant or breastfeeding women.
  • 2. Neuromuscular diseases, including neurogenic impairment of the face and patients with underlying neurological disorders.
  • 3. Patients with epilepsy or a previous seizure episode.
  • 4. Injection site infection (masseter or temporalis).
  • 5. Hypersensitivity or allergy to botulinum toxin or any of its excipients.

About Alexandria University

Alexandria University, a leading academic institution in Egypt, is dedicated to advancing medical research and improving healthcare outcomes through innovative clinical trials. With a strong emphasis on collaboration and interdisciplinary approaches, the university leverages its extensive resources and expertise to conduct rigorous studies that address pressing health challenges. By fostering partnerships with healthcare professionals, industry leaders, and regulatory bodies, Alexandria University aims to contribute to the global body of medical knowledge and enhance the quality of patient care through evidence-based findings.

Locations

Patients applied

0 patients applied

Trial Officials

Ragab S. Hassan, Professor

Study Director

Alexandria University

Gaafar N. Elhalawani, Lecturer

Study Chair

Alexandria University

Walaa A. Elwakil, Lecturer

Study Chair

University of Alexandria

Marwa M. Mancy, Bachelors

Principal Investigator

Alexandria University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported