Bruxism, SleepNCT06674733
Efficacy of Botulinum Toxin and Marjoram Oil Applications in Bruxism
A study testing Botox administration, Aromatherapy and Clinical evaluation in people with Bruxism, Sleep, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bruxism, Sleep
- What is being tested?
- Botox administration, Aromatherapy and Clinical evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Oct 2024to 28 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- Morning jaw muscle stiffness and spasms causing sleep disturbances
- Individuals older than 18 years,
- Individuals younger than 60 years,
- Provided informed voluntary consent
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Fatih, 34093
About this study
Official title: 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.
- Conditions
- Bruxism, Sleep
- Being tested
- Botox administration, Aromatherapy, Clinical evaluation, Imaging Time
- Keywords
- Bruxism, Botox, Origanum Majorana, Ultrasonography
- Medical subject headings
- Sleep Bruxism, Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox administrationProcedure or surgery
Treatment for bruxism
AromatherapyProcedure or surgery
treatment for stress-bruxism
Clinical evaluationProcedure or surgery
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 TimeProcedure or surgery
Ultrasonography and shear wave elastography examination will be performed before the procedure, one month after, and three months after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Botox group | Active comparator | Group 1 will consist of patients with bruxism complaints who are indicated for botox treatment and will receive BTX-A. Receives: 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) Receives: Procedure: Aromatherapy; Procedure: Clinical evaluation; Procedure: Imaging Time |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the 3-month follow-up after the procedure.
USG examination
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the 3-month follow-up after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start11 Oct 2024
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bruxism, SleepStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elifhan Alagoz, Asst. Prof., Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674733
- Sponsor's protocol ID
- 13.02.2024-E.140948
- Status last verified
- Sep 2025
- First submitted
- 30 Oct 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Botulinum Toxin and Marjoram Oil Applications in Sleep Bruxism
- ClinicalTrials.gov ID
- NCT06674733
- Acronym / sponsor ID
- 13.02.2024-E.140948
- Conditions
- Bruxism, Sleep
- Keywords
- Bruxism, Botox, Origanum Majorana, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox group | Active comparator | Procedure: Botox administration, Procedure: Clinical evaluation, Procedure: Imaging TimeGroup 1 will consist of patients with bruxism complaints who are indicated for botox treatment and will receive BTX-A. |
| aromatherapy group | Active comparator | Procedure: Aromatherapy, Procedure: Clinical evaluation, Procedure: Imaging TimeGroup 2 will consist of patients with bruxism complaints and will receive Origanum Majorana (marjoram oil) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botox administrationTreatment for bruxism | Procedure or surgery | Botox group |
| Aromatherapytreatment for stress-bruxism | Procedure or surgery | aromatherapy group |
| Clinical evaluationBefore 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 or surgery | Botox group, aromatherapy group |
| Imaging TimeUltrasonography and shear wave elastography examination will be performed before the procedure, one month after, and three months after the procedure. | Procedure or surgery | Botox group, aromatherapy group |
Primary outcome
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.
USG examination
Time frame: 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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- 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.Link provided by the sponsor.
- This study aimed to evaluate the correlation between the changes in masseter muscle thickness and clenching habits in bruxism patients treated with BT-A.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elifhan Alagoz, Asst. Prof. principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botox administration, Aromatherapy and Clinical evaluation in people with Bruxism, Sleep, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.