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Effect of Different Treatment Techniques on Masseter Muscle Thickness

NCT06593821 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-09-19

No results posted yet for this study

Summary

This study aims to evaluate the effects of different treatment techniques on masseter muscle thickness, pain levels and maximum mouth opening in patients with bruxism. The null hypothesis of the study is that there is no difference between the use of an occlusal splint and botulinum toxin on masseter muscle thickness in patients with bruxism.

Conditions

  • Bruxism
  • Masseter Muscle Hypertrophy

Interventions

DEVICE

Occlusal splint

The occlusal splint was fabricated from a 2 mm hard splinting resin material on the plaster model obtained by taking impressions of the patients\' upper jaw.

BEHAVIORAL

preventive advice

Control group given protective advice such as supporting the jaw when yawning, not chewing gum, not opening the mouth for too long and not opening it too wide, and chewing on both sides when eating.

DRUG

Botulinum toxin

A total of 50 U of botulinum toxin, 25 U in each muscle, was injected

Sponsors & Collaborators

  • Zonguldak Bulent Ecevit University

    lead OTHER

Principal Investigators

  • Şükriye E Geduk, Asst. Prof. · Zonguldak Bulent Ecevit University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-03
Primary Completion
2024-01-19
Completion
2024-01-19

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 NCT06593821 on ClinicalTrials.gov