- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07665398
Effect of Marjoram, Vetiver, and Lavender Oil in the Treatment of Bruxism
Study Overview
Status
Conditions
Detailed Description
Bruxism is a repetitive jaw muscle activity characterized by clenching or grinding of the teeth and/or bracing or thrusting of the mandible. Due to increasing evidence suggesting that it may serve a physiological purpose, bruxism has been defined as jaw muscle activity that may occur during sleep and/or wakefulness.
Various methods have been proposed for the treatment of bruxism. These treatment approaches include pharmacological treatments (such as muscle relaxants and clonazepam), orthopedic treatments (such as stabilization splints and rigid stabilization appliances), needling treatments (including acupuncture, botulinum toxin type A, and dry needling), physical and behavioral approaches (such as relaxation training, stress management, biofeedback, and sleep hygiene instructions), manual treatments including exercises (trigger point therapy, soft tissue techniques, exercises, postural corrections, joint mobilizations, and cervical spine treatment), and other physical therapy modalities (including low-level laser therapy, therapeutic ultrasound, and short-wave diathermy).
Manual therapy, therapeutic exercise, and their combination have been shown to effectively reduce pain and improve mandibular function. Massage therapy, which activates the pain-gate mechanism, is an effective treatment option for pain relief. It also stimulates the parasympathetic nervous system and helps restore muscle length and flexibility. In addition, massage therapy improves local blood circulation and promotes the production of endogenous opioids, leading to relaxing effects and reduced pain perception. These effects are of particular interest in the management of bruxism; however, this treatment approach has not been adequately investigated despite its promising results.
Massage therapy can be combined with aromatherapy, one of the most commonly used complementary therapy methods. Its therapeutic effects are based on stimulation of the olfactory system and absorption of active molecules through the skin. Various studies have investigated the analgesic effects of aromatherapy massage using lavender essential oil. Lavandula angustifolia is a well-known medicinal and aromatic plant with anti-inflammatory and analgesic properties. In addition, it has antiseptic, soothing, circulation-stimulating, and cell-regenerating effects. Lavender oil has been reported to reduce pain in patients with various conditions, including neuropathic pain, rheumatoid arthritis, burns, and cancer-related pain. Apart from lavender oil, marjoram oil may contribute to pain control and anxiety reduction, while vetiver oil is known for its sedative effects. However, the effects of aromatherapy massage using these essential oils have not been adequately investigated in patients with bruxism.
The aim of this study is to evaluate the effects of lavender, marjoram, and vetiver essential oils administered through aromatherapy massage in patients with bruxism. Objective outcomes will be assessed through ultrasonographic evaluation of the masseter muscle, while subjective outcomes will be evaluated using patient-reported questionnaires. The findings of this study may contribute to the development of complementary treatment approaches for the management of bruxism.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Merkez
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Bilecik, Merkez, Turkey (Türkiye), 11100
- Bilecik Seyh Edebali University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Patients between 18-25
- Patients with full dentition including 2nd molars
- Patients without facial asymmetry
- Patients without history of sensitivity or allergy to plants
- Patients without olfactory disorders
Exclusion Criteria:
• Patients with systemic (asthma history) and/or neuromuscular disease
- Patients with orofacial pain not caused by bruxism
- Temporomandibular joint (TMJ) surgery or injection history
- Use of any medical drug affecting the muscular system
- Patients with developmental deformity or surgery history in the maxillofacial region (facial trauma history, resection history, etc.)
- TMJ pathologies (major condylar changes seen on panoramic radiograph)
- Radiotherapy and/or chemotherapy history
- Ongoing orthodontic treatment
- Removable prosthesis use
- Inflammatory connective tissue diseases
- Pregnancy
- Obstructive sleep apnea
- Local skin infection over the myofascial area
- Reluctance to take responsibility for the work
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: Control Group
Participants receive carrier oil (sesame oil) administered through inhalation and extraoral massage following the same protocol as the intervention group.
Outcomes are evaluated using ultrasonographic measurements and patient-reported questionnaires.
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Participants receive carrier oil (sesame oil) administered through inhalation and extraoral massage according to the same protocol used in the intervention group.
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Experimental: Aromatherapy Group
Participants receive aromatherapy by inhalation twice daily and extraoral massage once daily throughout the study period.
Outcomes are evaluated using ultrasonographic measurements and patient-reported questionnaires.
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Participants receive aromatherapy using a proprietary essential oil blend (Lavender Lavandula angustifolia, Marjoram Origanum majorana, and Vetiver Vetiveria zizanioides; Art De Huile®, formulated by Hülya Kayhan).
The blend is administered by inhalation twice daily and extraoral massage once daily throughout the study period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Masseter Muscle Elasticity
Time Frame: Baseline to Week 4
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Assessment of changes in masseter muscle elasticity using shear-wave elastography measured by ultrasonography.
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Baseline to Week 4
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Change in Masseter Muscle Thickness
Time Frame: Baseline to Week 4
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Assessment of changes in masseter muscle thickness measured by ultrasonography.
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Baseline to Week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Bruxism-Related Symptoms
Time Frame: Baseline to Week 4
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Assessment of changes in bruxism-related symptoms (jaw pain, headache, tooth sensitivity, fatigue, and perceived stress/anxiety) using the Visual Analog Scale (VAS).
Each symptom is rated from 0 (no symptom) to 10 (worst imaginable symptom).
Higher scores indicate more severe symptoms.
A study-specific patient-reported questionnaire is also used to document the presence and characteristics of bruxism-related symptoms.
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Baseline to Week 4
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Patient Satisfaction With Treatment
Time Frame: Week 4
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Assessment of participant satisfaction with the intervention using a study-specific patient-reported questionnaire.
Treatment satisfaction is rated on a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied).
Higher scores indicate greater treatment satisfaction.
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Week 4
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Collaborators and Investigators
Publications and helpful links
General Publications
- Armijo-Olivo S, Pitance L, Singh V, Neto F, Thie N, Michelotti A. Effectiveness of Manual Therapy and Therapeutic Exercise for Temporomandibular Disorders: Systematic Review and Meta-Analysis. Phys Ther. 2016 Jan;96(1):9-25. doi: 10.2522/ptj.20140548. Epub 2015 Aug 20.
- Medlicott MS, Harris SR. A systematic review of the effectiveness of exercise, manual therapy, electrotherapy, relaxation training, and biofeedback in the management of temporomandibular disorder. Phys Ther. 2006 Jul;86(7):955-73.
- Palinkas M, De Luca Canto G, Rodrigues LA, Bataglion C, Siessere S, Semprini M, Regalo SC. Comparative Capabilities of Clinical Assessment, Diagnostic Criteria, and Polysomnography in Detecting Sleep Bruxism. J Clin Sleep Med. 2015 Nov 15;11(11):1319-25. doi: 10.5664/jcsm.5196.
- Capellini VK, de Souza GS, de Faria CR. Massage therapy in the management of myogenic TMD: a pilot study. J Appl Oral Sci. 2006 Jan;14(1):21-6. doi: 10.1590/s1678-77572006000100005.
- Nasiri A, Mahmodi MA, Nobakht Z. Effect of aromatherapy massage with lavender essential oil on pain in patients with osteoarthritis of the knee: A randomized controlled clinical trial. Complement Ther Clin Pract. 2016 Nov;25:75-80. doi: 10.1016/j.ctcp.2016.08.002. Epub 2016 Aug 3.
- Seifert O, Baerwald C. [Stimulation of the vagus nerve as a therapeutic principle. German Version]. Z Rheumatol. 2023 Aug;82(6):462-471. doi: 10.1007/s00393-023-01390-x. Epub 2023 Jul 25. German.
- Bennett R. Myofascial pain syndromes and their evaluation. Best Pract Res Clin Rheumatol. 2007 Jun;21(3):427-45. doi: 10.1016/j.berh.2007.02.014.
- Johnson JR, Rivard RL, Griffin KH, Kolste AK, Joswiak D, Kinney ME, Dusek JA. The effectiveness of nurse-delivered aromatherapy in an acute care setting. Complement Ther Med. 2016 Apr;25:164-9. doi: 10.1016/j.ctim.2016.03.006. Epub 2016 Mar 7.
- Gok Metin Z, Arikan Donmez A, Izgu N, Ozdemir L, Arslan IE. Aromatherapy Massage for Neuropathic Pain and Quality of Life in Diabetic Patients. J Nurs Scholarsh. 2017 Jul;49(4):379-388. doi: 10.1111/jnu.12300. Epub 2017 Jun 12.
- Ariji Y, Nakayama M, Nishiyama W, Ogi N, Sakuma S, Katsumata A, Kurita K, Ariji E. Potential clinical application of masseter and temporal muscle massage treatment using an oral rehabilitation robot in temporomandibular disorder patients with myofascial pain. Cranio. 2015 Oct;33(4):256-62. doi: 10.1080/08869634.2015.1097303. Epub 2015 Dec 29.
- Pessoa DR, Costa DR, Prianti BM, Costa DR, Delpasso CA, Arisawa EALS, Nicolau RA. Association of facial massage, dry needling, and laser therapy in Temporomandibular Disorder: case report. Codas. 2018 Nov 29;30(6):e20170265. doi: 10.1590/2317-1782/20182017265.
- Fernandez-de-las-Penas C, Svensson P. Myofascial Temporomandibular Disorder. Curr Rheumatol Rev. 2016;12(1):40-54. doi: 10.2174/1573397112666151231110947.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Nervous System Diseases
- Mental Disorders
- Tooth Diseases
- Sleep Wake Disorders
- Parasomnias
- Behavior
- Habits
- Bruxism
- Sleep Bruxism
- Epidemiologic Methods
- Therapeutics
- Lipids
- Public Health
- Environment and Public Health
- Mind-Body Therapies
- Complementary Therapies
- Food
- Diet, Food, and Nutrition
- Physiological Phenomena
- Food and Beverages
- Psychotherapy
- Behavioral Disciplines and Activities
- Plant Preparations
- Biological Products
- Complex Mixtures
- Plant Oils
- Oils
- Dietary Fats
- Fats
- Dietary Fats, Unsaturated
- Sensory Art Therapies
- Phytotherapy
- Fats, Unsaturated
- Aromatherapy
- Sesame Oil
- Carrier State
Other Study ID Numbers
- 2023/346
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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