Clinical trial NCT05562531: Botulinum Toxin Administration on Masticatory Performance
Official title: Evaluation of the Chewing Performance and Nutritional Status of the Patients Diagnosed With Bruxism After Botulinum Toxin Application: Follow-up Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Temporomandibular Disorder
Bruxism
Keywords: Botulinum Toxins, Type A
Mastication
Nutritional Status
Bruxism
Chewing
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who applied to the Marmara University Faculty of Dentistry Department of Oral and Maxillofacial Surgery for bruxism and joint pain will be included in the study. It is aimed to invite all patients who applied to the clinic to the research.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in the masticatory performance at 6 months
timeFrame: 6 months
measure: Change from baseline in the nutritional status at 6 months
timeFrame: 6 months
measure: Change from baseline in the BMI at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change in pain intensity
timeFrame: 6 months
measure: Change from baseline in the anxiety status at 6 months
timeFrame: 6 months
measure: Change in chewing ability
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Dentistry
Study officials:
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