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

NCT07545200 | Completed

• 1 other identifier: MasseterMuscle
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

bruxism; Botulinum Toxin A; Masseter Muscle; Ultrasonography; Muscle Thickness; Fractal Analysis; Histogram Analysis

Outcome Measures

Primary Outcomes (1)

• Masseter Muscle Thickness

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

  Baseline, Day 14, Day 90

Secondary Outcomes (3)

• Pain Intensity (VAS Score)

  Baseline, Day 14, Day 90

• Fractal Dimension of Masseter Muscle

  Baseline, Day 14, Day 90

• Ultrasound Echotexture (Histogram Analysis)

  Baseline, Day 14, Day 90

Study Arms (1)

Botulinum Toxin Group

EXPERIMENTAL

Participants received bilateral botulinum toxin injections into the masseter muscle using a standardized injection protocol. Clinical and ultrasonographic assessments were performed at baseline, 14 days, and 90 days post-treatment.

Drug: Botulinum Toxin A (Botox )

Interventions

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.

Botulinum Toxin Group

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaras Sutcu Imam University

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

Location

MeSH Terms

Conditions

Bruxism; Masticatory Muscles, Hypertrophy of

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking was applied in this study. All participants received the same intervention, and both participants and investigators were aware of the treatment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single-group, non-randomized interventional study in which all participants received bilateral botulinum toxin injections into the masseter muscle. Outcomes were assessed longitudinally at baseline, 14 days, and 90 days post-intervention. Each participant served as their own control.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start: September 30, 2025
• Primary Completion: February 15, 2026
• Study Completion: February 15, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)