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Ultrasonographic Evaluation of Masseter Muscle Changes After Botulinum Toxin Injection in Bruxism Patients

NCT07545200 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2026-04-22

No results posted yet for this study

Summary

This prospective pilot study aimed to evaluate short-term clinical and ultrasonographic changes in the masseter muscle following botulinum toxin injection in patients with bruxism. Clinical assessments included pain evaluation using the Visual Analog Scale (VAS), while ultrasonographic evaluation included measurement of masseter muscle thickness and quantitative texture analysis using fractal dimension and histogram parameters. Measurements were performed at baseline, 14 days, and 90 days after treatment. The study aimed to assess both macroscopic and microstructural changes in the muscle tissue.

Conditions

  • Bruxism
  • Myofascial Pain
  • Masseter Muscle Hypertrophy

Interventions

DRUG

Botulinum Toxin A (Botox )

Botulinum toxin A was injected bilaterally into the masseter muscle using a standardized injection protocol. Injections were administered at three points in the most prominent region of the muscle. Clinical and ultrasonographic evaluations were performed at baseline, 14 days, and 90 days after injection.

Sponsors & Collaborators

  • Kahramanmaras Sutcu Imam University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-02-15
Completion
2026-02-15

Countries

  • Turkey (Türkiye)

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 NCT07545200 on ClinicalTrials.gov