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Repeated Botulinum Toxin Type A Injections on Intramuscular Fat Accumulation in Individuals With Sleep Bruxism.

NCT07266064 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-12-05

No results posted yet for this study

Summary

This study investigates whether repeated botulinum toxin type A (BoNT-A) injections used to manage sleep bruxism lead to structural changes-specifically intramuscular fat accumulation-in the masseter muscle. Adults with probable sleep bruxism receive BoNT-A injections every six months and undergo ultrasound evaluations before each injection. By tracking fat percentage in the masseter muscle over multiple treatment cycles, the study aims to determine whether long-term BoNT-A use causes progressive structural alterations or remains safe for repeated clinical use.

Conditions

  • Bruxism
  • Bruxism, Sleep
  • Bruxism, Sleep-Related

Interventions

OTHER

Botilinum Toxin injection

This prospective longitudinal interventional study included adults with probable sleep bruxism who received bilateral BoNT-A injections every six months, with ultrasonographic assessments also performed at six-month intervals, immediately before each new injection. The protocol therefore comprised four injection cycles and five ultrasound sessions. Ultrasonographic evaluations were conducted before the first injection and six months after each subsequent injection to quantify intramuscular fat percentage at rest and during maximum voluntary contraction. Fat area percentage was computed from standardized B-mode images using binary segmentation in CT-Analyzer software.

Sponsors & Collaborators

  • Melek Volkan Yazici

    lead OTHER

Principal Investigators

  • GOKHAN YAZICI, A/Prof · Gazi University

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-02
Primary Completion
2025-11-20
Completion
2025-11-20

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 NCT07266064 on ClinicalTrials.gov