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Botulinum Toxin Administration on Masticatory Performance | Clinical Trials | Clareo Health

UNKNOWN

Botulinum Toxin Administration on Masticatory Performance

Evaluation of the Chewing Performance and Nutritional Status of the Patients Diagnosed With Bruxism After Botulinum Toxin Application: Follow-up Study

NCT05562531•Marmara University

View on ClinicalTrials.gov

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

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

Marmara University School of Dentistry

Istanbul, Turkey (Türkiye)

Key Dates

Start Date

May 1, 2022

Primary Completion Date

October 1, 2023

Completion Date

December 1, 2023

Last Updated

December 7, 2023

Enrollment

ESTIMATED participants

Conditions

Temporomandibular DisorderBruxism

Occlusal Equilibration vs. Sham Therapies for TMDs: Post-Trial Follow-up (OEST)

NCT07445516

Temporomandibular Disorders (TMD)Myalgia of Mastication Muscle+1 more

View study

RECRUITINGNA

Effect of Occlusal Splint on Head and Neck Muscles in Patients With Bruxism and Myofascial Pain

NCT07090551

Myofacial Pain SyndromeLocal Myalgia+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 7, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Botulinum Toxin Administration on Masticatory Performance

Inclusion Criteria

Exclusion Criteria

Occlusal Equilibration vs. Sham Therapies for TMDs: Post-Trial Follow-up (OEST)

Effect of Occlusal Splint on Head and Neck Muscles in Patients With Bruxism and Myofascial Pain

Behavioral Interventions for Controlling Oral Behaviors

K23- Physical Self Regulation vs Placebo

Tele-Rehabilitation in Patients With Temporomandibular Dysfunction

Effectiveness of Visceral Manual Therapy in Bruxist Patients