Skip to main content
OpenTrials
Completed

NCT Number: NCT06674733

Efficacy of Botulinum Toxin and Marjoram Oil Applications in Bruxism

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Botox administration

Procedure

Treatment for bruxism

Aromatherapy

Procedure

treatment for stress-bruxism

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

Imaging Time

Procedure

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

Primary outcomes

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

    Time frame: 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.

  2. USG examination

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

  3. Evaluation of Changes in Bruxism Symptoms with scales (Subject Global Aesthetic Improvement Scale)

    Time frame: 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.

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

    Time frame: 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.

  5. Satisfaction Survey

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 5, 2024
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.