Efficacy of Botulinum Toxin and Marjoram Oil Applications in Bruxism

September 15, 2025 updated by: Bezmialem Vakif University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Fatih
      • Istanbul, Fatih, Turkey (Türkiye), 34093
        • Bezmialem Vakif University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Botox group
Group 1 will consist of patients with bruxism complaints who are indicated for botox treatment and will receive BTX-A.
Procedure: Botox administration
Treatment for 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.
Active Comparator: aromatherapy group
Group 2 will consist of patients with bruxism complaints and will receive Origanum Majorana (marjoram oil)
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: Aromatherapy
treatment for stress-bruxism
Procedure: Imaging Time
Ultrasonography and shear wave elastography examination will be performed before the procedure, one month after, and three months after the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the 3-month follow-up after the procedure.
USG examination
Time Frame: From enrollment to the 3-month follow-up after the procedure.
From enrollment to the 3-month follow-up after the procedure.
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.
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)
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.
From enrollment to the 3-month follow-up after the procedure.
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.
From enrollment to the 3-month follow-up after the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Principal Investigator: Elifhan Alagoz, Asst. Prof., Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2024

Primary Completion (Actual)

March 28, 2025

Study Completion (Actual)

March 28, 2025

Study Registration Dates

First Submitted

October 30, 2024

First Submitted That Met QC Criteria

November 3, 2024

First Posted (Actual)

November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13.02.2024-E.140948

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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