Evaluation of BTX Injections in Treatment of Bruxism

NCT05980559 | Unknown Phase 3

• 1 other identifier: Botulinum toxin in bruxism
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Botulinum toxin; Electromyographic; occlusense

Outcome Measures

Primary Outcomes (1)

• Change in electromyographic activity of temporalis and masseter muscles bilaterally.

  Analyze the electromyographic activity of temporalis and masseter muscles bilaterally. The acquisitions will be performed twice with the rest position of the mandible (RPM) for 10 seconds, in maximal intercuspal position for 5 seconds, and maximal teeth clenching with 10-mm thick cotton rolls between the posterior teeth for 5 seconds, bilaterally, and the median of values will be obtained. The unit of measurement used in the Electromyographic records will be microvolts (μV).

  Assessment will be done before the injection versus 1 and 3 months after injection

Secondary Outcomes (3)

• Change in Pain Assessment

  Assessment will be done before the injection versus 1 and 3 months after injection

• Change in maximum bite force

  Assessment will be done before the injection versus 1 and 3 months after injection

• Change in Bruxism symptom questionnaire

  questionnaire will be done before the injection versus 1 and 3 months after injection

Study Arms (1)

One Group

EXPERIMENTAL

Patients will be injected with 50 MU of botulinum toxin and Surface qualitative Electromyography, maximum bite force and visual pain scale will be taken before and after 1, 3 months

Drug: Xeomin

Interventions

Xeomin DRUG

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)

One Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient between 20 and 60 years of age.
• Pain related to the masseter muscles and TMJ area due to bruxism.
• Patient who has never received botulinum toxins.
• Patient who did not respond to the conventional treatments (analgesic, physiotherapy, relaxation technique and maxillary retainer).

You may not qualify if:

• Pregnant or breastfeeding women.
• Neuromuscular diseases, including neurogenic impairment of the face and patients with underlying neurological disorders.
• Patients with epilepsy or a previous seizure episode.
• Injection site infection (masseter or temporalis).
• Hypersensitivity or allergy to botulinum toxin or any of its excipients.

Sponsors & Collaborators

• Alexandria University: lead

MeSH Terms

Conditions

Bruxism

Interventions

incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Study Officials

• Ragab S. Hassan, Professor

  Alexandria University

  STUDY DIRECTOR

• Gaafar N. Elhalawani, Lecturer

  Alexandria University

  STUDY CHAIR

• Walaa A. Elwakil, Lecturer

  University of Alexandria

  STUDY CHAIR

• Marwa M. Mancy, Bachelors

  Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marwa M. Mohmed, Bachelors

CONTACT

00201224979900; Marwa.mohamed.dent@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: August 8, 2023
• Study Start: January 15, 2024
• Primary Completion: January 15, 2024
• Study Completion: April 15, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01