Skip to main content
OpenTrials
Completed

NCT Number: NCT07545200

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kahramanmaras Sutcu Imam University

Kahramanmaraş, Choose A State, 46000, Turkey (Türkiye)

About this study

This study investigated the short-term effects of botulinum toxin injection on the masseter muscle in patients with bruxism using quantitative ultrasonographic methods. All participants received bilateral botulinum toxin injections into the masseter muscle using a standardized technique. Ultrasonographic examinations were performed using a high-frequency linear probe. Masseter muscle thickness was measured at a standardized anatomical location during maximal clenching.

For quantitative texture analysis, a fixed-size region of interest (ROI) was placed in the central intramuscular portion of the masseter muscle while avoiding fascia, bone, and artifacts. Fractal analysis was performed using the box-counting method to assess structural complexity, while histogram analysis was used to evaluate grayscale pixel distribution reflecting echotexture characteristics.

Clinical and ultrasonographic measurements were recorded at baseline, 14 days, and 90 days post-injection. The study aimed to determine whether botulinum toxin induces not only functional and morphological changes but also microstructural alterations in muscle tissue.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults aged 18-60 years Clinically diagnosed with bruxism Scheduled for botulinum toxin injection into the masseter muscle Willing to participate and provided written informed consent Completed all follow-up visits (baseline, Day 14, and Day 90)

Exclusion criteria

Previous botulinum toxin injection to the masseter muscle Presence of neuromuscular disorders affecting masticatory muscles History of temporomandibular joint surgery Pregnancy or breastfeeding Presence of trauma, infection, or mass in the masseter region Any condition that may interfere with ultrasonographic evaluation Failure to complete follow-up visits

Treatment and study plan

Botulinum Toxin A (Botox )

Drug

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.

Primary outcomes

  1. Masseter Muscle Thickness

    Time frame: Baseline, Day 14, Day 90

    Change in masseter muscle thickness measured in millimeters using ultrasonography at baseline, 14 days, and 90 days following botulinum toxin injection.

Secondary outcomes

  1. Pain Intensity (VAS Score)

    Time frame: Baseline, Day 14, Day 90

    Change in pain intensity measured using the Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain) at baseline, 14 days, and 90 days after botulinum toxin injection.

  2. Fractal Dimension of Masseter Muscle

    Time frame: Baseline, Day 14, Day 90

    Change in fractal dimension values derived from ultrasonographic images using region-of-interest (ROI)-based analysis to assess microstructural complexity at baseline, 14 days, and 90 days post-intervention.

  3. Ultrasound Echotexture (Histogram Analysis)

    Time frame: Baseline, Day 14, Day 90

    Change in grayscale histogram parameters obtained from ultrasound images of the masseter muscle, reflecting echotexture characteristics, at baseline, 14 days, and 90 days after treatment.

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

Quantitative Ultrasonographic Assessment of Masseter Muscle Changes Following Botulinum Toxin Injection in Patients With Bruxism: A Prospective Pilot Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.