Clinical trial NCT06674733: Efficacy of Botulinum Toxin and Marjoram Oil Applications in Bruxism
Official title: Evaluation of the Efficacy of Botulinum Toxin and Marjoram Oil Applications in Sleep Bruxism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bruxism, Sleep
Keywords: Bruxism
Botox
Origanum Majorana
Ultrasonography
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. Fractal analysis of the condyle and corpus regions will be conducted on panoramic radiographs before treatment and 3 months after 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.


Eligibility criteria: Inclusion Criteria:

1. Patients who have complaints of teeth clenching or grinding,
2. Patients who present with tired or tense jaw muscles or a locked jaw that cannot fully open or close,
3. Patients who experience jaw, neck, or facial pain due to teeth grinding,
4. Patients who feel ear pain that mimics an ear problem despite having no ear issues,
5. Patients with abnormal tooth wear, sounds associated with bruxism, and discomfort in the jaw muscles,
6. Patients who have sleep problems due to jaw, neck, or facial pain complaints,
7. Individuals older than 18 years,
8. Individuals younger than 60 years,
9. Patients who are willing to participate in the study.

Exclusion Criteria:

1. Patients who have had masseter Botox within the last 6 months,
2. Patients who have used a night guard for bruxism in the last 6 months,
3. Patients with a history of alcohol or substance abuse,
4. Patients under the age of 18,
5. Patients over the age of 60,
6. Pregnant women or those suspected of being pregnant,
7. Postpartum and breastfeeding women,
8. Patients with infections or skin diseases at the injection site,
9. Patients diagnosed with asthma or COPD,
10. Patients allergic to or who have skin reactions to BTX-A and/or aromatherapy oils.

Primary outcomes:
measure: Evaluation of Changes in Bruxism Symptoms with scales (The Fonseca Anamnestic Index)
timeFrame: From enrollment to the 3-month follow-up after the procedure.
measure: USG examination
timeFrame: From enrollment to the 3-month follow-up after the procedure.
measure: Evaluation of Changes in Bruxism Symptoms with scales (Subject Global Aesthetic Improvement Scale)
timeFrame: From enrollment to the 3-month follow-up after the procedure.
measure: Evaluation of Changes in Bruxism Symptoms with scales (Basic Scale on Insomnia Complaint and Quality of Sleep)
timeFrame: From enrollment to the 3-month follow-up after the procedure.
measure: Satisfaction Survey
timeFrame: From enrollment to the 3-month follow-up after the procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
state: Fatih
Study officials:
affiliation: Bezmialem Vakif University
name: Elifhan Alagoz, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References: