Efficacy of Botulinum Toxin and Marjoram Oil Applications in Bruxism

Not Applicable

Completed

• Conditions: Bruxism, Sleep

• Registration Number: NCT06674733
• Lead Sponsor: Bezmialem Vakif University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-11
• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-11-03
• Study First Posted: 2024-11-05
• Primary Completion: 2025-03-28
• Study Completion: 2025-03-28
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-15
• Last Update Posted: 2025-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Self-reported teeth clenching or grinding
2. Tenderness or fatigue in the masticatory muscles upon palpation
3. Increased morning muscle pain
4. Localized myofascial pain in the jaw, face, or neck region
5. Irregular or excessive enamel wear consistent with bruxism
6. Grinding sounds during sleep confirmed by a partner
7. Morning jaw muscle stiffness and spasms causing sleep disturbances
8. Individuals older than 18 years,
9. Individuals younger than 60 years,
10. Provided informed voluntary consent

Exclusion Criteria

1. Botulinum toxin injection into the masseter muscle within the last 6 months
2. Use of night guards
3. Pathology or history of surgery involving the masseter muscle or parotid gland
4. Benign or malignant tumors in the mandibular region
5. History of alcohol or substance abuse
6. Age below 18 or above 60
7. Pregnancy, postpartum period, or breastfeeding
8. Infection or dermatological lesions at the injection site
9. Diagnosis of chronic obstructive pulmonary disease (COPD) or asthma
10. Known allergy or skin reaction to botulinum toxin A or essential oils used in aromatherapy
11. Use of muscle relaxants or other medications that may affect muscle function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of Changes in Bruxism Symptoms with scales (The Fonseca Anamnestic Index)	From enrollment to the 3-month follow-up after the procedure.	It is an index ranging from 0 to 100 for classifying the severity of TMD. A score of 0-15 indicates no TMD, 20-40 indicates mild TMD, 25-65 indicates moderate TMD, and 70-100 indicates severe TMD.
USG examination	From enrollment to the 3-month follow-up after the procedure.
Evaluation of Changes in Bruxism Symptoms with scales (Subject Global Aesthetic Improvement Scale)	From enrollment to the 3-month follow-up after the procedure.	It is a scoring system between 0 and 4. A score of 0 indicates that the condition is worse than before the procedure, while a score of 4 indicates an ideal outcome.
Evaluation of Changes in Bruxism Symptoms with scales (Basic Scale on Insomnia Complaint and Quality of Sleep)	From enrollment to the 3-month follow-up after the procedure.	It is a scoring system between 0 and 28. A score of 0 indicates no problems related to sleep, while a score of 28 represents severe insomnia complaints and poor sleep quality.
Satisfaction Survey	From enrollment to the 3-month follow-up after the procedure.	It is a scoring system between 1 and 5. A score of 1 indicates complete dissatisfaction, while a score of 5 indicates a high level of satisfaction.

Trial Locations

Locations (1)

Bezmialem Vakif University; Istanbul, Fatih, Turkey (Türkiye)