Efficacy of Botulinum Toxin and Marjoram Oil Applications in Bruxism

NCT06674733 | Completed

• 1 other identifier: 13.02.2024-E.140948
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bruxism, Sleep

Keywords

Bruxism; Botox; Origanum Majorana; Ultrasonography

Outcome Measures

Primary Outcomes (5)

• Evaluation of Changes in Bruxism Symptoms with scales (The Fonseca Anamnestic Index)

  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.

  From enrollment to the 3-month follow-up after the procedure.

• 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)

  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.

  From enrollment to the 3-month follow-up after the procedure.

• Evaluation of Changes in Bruxism Symptoms with scales (Basic Scale on Insomnia Complaint and Quality of Sleep)

  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.

  From enrollment to the 3-month follow-up after the procedure.

• Satisfaction Survey

  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.

  From enrollment to the 3-month follow-up after the procedure.

Study Arms (2)

Botox group

ACTIVE COMPARATOR

Group 1 will consist of patients with bruxism complaints who are indicated for botox treatment and will receive BTX-A.

Procedure: Botox administration; Procedure: Clinical evaluation; Procedure: Imaging Time

aromatherapy group

ACTIVE COMPARATOR

Group 2 will consist of patients with bruxism complaints and will receive Origanum Majorana (marjoram oil)

Procedure: Aromatherapy; Procedure: Clinical evaluation; Procedure: Imaging Time

Interventions

Botox administration PROCEDURE

Treatment for bruxism

Botox group

Aromatherapy PROCEDURE

treatment for stress-bruxism

aromatherapy group

Clinical evaluation PROCEDURE

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

Botox group; aromatherapy group

Imaging Time PROCEDURE

Ultrasonography and shear wave elastography examination will be performed before the procedure, one month after, and three months after the procedure.

Botox group; aromatherapy group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Links

• The purpose of this study was to evaluate the efficacy and safety of onabotulinumtoxin A and Chinese botulinum toxin type A (CBA) for masseter reduction using elastography and electromyographic measurement.
• This study aimed to evaluate the correlation between the changes in masseter muscle thickness and clenching habits in bruxism patients treated with BT-A.
• This study aimed to investigate the effect of inhalation of marjoram essential oil at work on the stress and anxiety levels of nurses in a COVID-19 ICU.

MeSH Terms

Conditions

Sleep Bruxism; Bruxism

Interventions

Aromatherapy; Time-Lapse Imaging

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Habits; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities; Photography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Elifhan Alagoz, Asst. Prof.

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 5, 2024
• Study Start: October 11, 2024
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)