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Botulinum Toxin Administration on Masticatory Performance

M

Marmara University

Status

Enrolling

Conditions

Bruxism
Temporomandibular Disorder

Study type

Observational

Funder types

Other

Identifiers

NCT05562531
MU_DHF_SBF_01

Details and patient eligibility

About

This study aimed to evaluate the effect of botulinum toxin type A (BTX-A) injection on masticatory performance and nutritional status in temporomandibular disorder patients with bruxism caused by both intra-articular and extra-articular pathologies based on Research Diagnostic Criteria for temporomandibular disorders (TMD). The baseline and end masticatory performance, pain intensity, nutrition and anxiety statuses, and anthropometric measurements will be compared.

Full description

The main purpose of this study is to determine the effect of BTX-A injection on masticatory performance and nutritional status in TMD patients with bruxism.

Sub-objectives of the study;

Determination of the effect of BTX-A on masticatory performance Determination of the effect of BTX-A on pain intensity Determination of the effect of BTX-A on anthropometric measurements Determination of the effect of BTX-A on nutritional status Determination of the effect of BTX-A on anxiety status.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Between 18 and 50 years old,
  • Male or female,
  • Able to communicate
  • Able to read and write
  • Volunteer to participate in the study,
  • At least 3 months of splint treatment and no results
  • Having Class 1 molar occlusion and not using removable prostheses
  • Marmara University, Faculty of Medicine, Department of Oral and Maxillofacial Surgery, patients diagnosed with bruxism or myofascial pain in masticatory muscles will be included in the study.

Exclusion criteria

  • Sensitivity to botulinum toxin,
  • Have received botox treatment in the last 6 months,
  • Injection site infection
  • Pregnant or lactating women
  • Those with diseases that may cause systemic neuropathy such as diabetes, hypertension, kidney disease,
  • Those who do not want to sign the consent form,
  • Patients with a history of malignancy, radiotherapy or chemotherapy will be excluded from the study.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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