NCT06674733

Efficacy of Botulinum Toxin and Marjoram Oil Applications in Bruxism

Evaluation of the Efficacy of Botulinum Toxin and Marjoram Oil Applications in Sleep Bruxism

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Bezmialem Vakif University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Objective: Bruxism is defined as clenching or grinding teeth unconsciously. It can be categorized under two subheadings: sleep and awake bruxism. This study aims to investigate the effectiveness of botox applications, a current approach in the treatment of sleep bruxism, and to evaluate the effectiveness of alternative therapies like aromatherapeutic oils. The study will compare and assess the efficacy of these methods. Materials and Methods: This prospective study will be conducted between March 2024 and January 2025 at Bezmialem Vakıf University, Faculty of Dentistry, Department of Oral and Maxillofacial Radiology, with patients aged between 18 and 60 who have presented complaints of clenching/grinding teeth, sleep bruxism, jaw, neck, or face pain, and insomnia. The patients diagnosed with sleep bruxism will be divided into two groups, each consisting of 15 patients. The first group will include 15 patients with sleep bruxism who will receive botulinum toxin-A (BTX-A) injections, and the second group will consist of 15 patients who will use marjoram oil as an alternative treatment. Ultrasound imaging will assess the thickness and stiffness of the masseter muscle before treatment, and at 1 and 3 months post-treatment. Clinical evaluations will also be performed before treatment, and at 1 and 3 months post-treatment using scoring systems.

Conditions

• Bruxism, Sleep

Interventions

Type	Name	Description
PROCEDURE	Botox administration	Treatment for bruxism
PROCEDURE	Aromatherapy	treatment for stress-bruxism
PROCEDURE	Clinical evaluation	Before the procedure, and at 1 month and 3 months after the procedure, the Fonseca questionnaire, symptom assessment questionnaire, and Basic Scale on Insomnia Complaint and Quality of Sleep (BaSIQS) will be administered. At the 1st month and 3rd month, Subject Global Aesthetic Improvement Scale (GAIS), and satisfaction questionnaire will be administered
PROCEDURE	Imaging Time	Ultrasonography and shear wave elastography examination will be performed before the procedure, one month after, and three months after the procedure.

Timeline

• Start date: 2024-10-11
• Primary completion: 2025-03-28
• Completion: 2025-03-28
• First posted: 2024-11-05
• Last updated: 2025-09-19

Locations

1 site across 1 country: Turkey (Türkiye)