NCT07665398

Brief Summary

The aim of this study was to investigate the possible effects of the use of lavender, marjoram and vetiver oil via inhalation and/or massage application on the treatment of bruxism.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Sep 2024Jan 2027

Study Start

First participant enrolled

September 2, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

July 2, 2026

Status Verified

June 1, 2026

Enrollment Period

2.3 years

First QC Date

June 18, 2026

Last Update Submit

June 30, 2026

Conditions

Keywords

bruxismsleep bruxismaromatherapylavender oilmarjoram oilvetiver oilessentials oilmasticatory musclemasseter muscleultrasonographymyofascial pain

Outcome Measures

Primary Outcomes (2)

  • Change in Masseter Muscle Elasticity

    Assessment of changes in masseter muscle elasticity using shear-wave elastography measured by ultrasonography.

    Baseline to Week 4

  • Change in Masseter Muscle Thickness

    Assessment of changes in masseter muscle thickness measured by ultrasonography.

    Baseline to Week 4

Secondary Outcomes (2)

  • Change in Bruxism-Related Symptoms

    Baseline to Week 4

  • Patient Satisfaction With Treatment

    Week 4

Study Arms (2)

Aromatherapy Group

EXPERIMENTAL

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.

Other: Aromatherapy with Essential Oil Blend (Lavender, Marjoram, Vetiver)

Control Group

PLACEBO COMPARATOR

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.

Other: Carrier Oil (Sesame Oil)

Interventions

Participants receive carrier oil (sesame oil) administered through inhalation and extraoral massage according to the same protocol used in the intervention group.

Control Group

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.

Aromatherapy Group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female participants are eligible for this study, as the study population is restricted to women aged 18 to 25 years according to the study protocol.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bilecik Seyh Edebali University

Bilecik, Merkez, 11100, Turkey (Türkiye)

Location

Related Publications (12)

  • 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.

    PMID: 37490129BACKGROUND
  • 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.

    PMID: 17602992BACKGROUND
  • 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.

    PMID: 26235152BACKGROUND
  • 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.

    PMID: 27062964BACKGROUND
  • 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.

    PMID: 28605119BACKGROUND
  • 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.

    PMID: 27863613BACKGROUND
  • 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.

    PMID: 16813476BACKGROUND
  • 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.

    PMID: 26714800BACKGROUND
  • 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.

    PMID: 19089025BACKGROUND
  • 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.

    PMID: 30517267BACKGROUND
  • 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.

    PMID: 26294683BACKGROUND
  • Fernandez-de-las-Penas C, Svensson P. Myofascial Temporomandibular Disorder. Curr Rheumatol Rev. 2016;12(1):40-54. doi: 10.2174/1573397112666151231110947.

    PMID: 26717949BACKGROUND

Related Links

MeSH Terms

Conditions

BruxismSleep Bruxism

Interventions

AromatherapyCarrier StateSesame Oil

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehaviorParasomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and ActivitiesEpidemiologic MethodsPublic HealthEnvironment and Public HealthDietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants with bruxism are assigned to one of two parallel groups. The intervention group receives aromatherapy with lavender, marjoram, and vetiver essential oils administered through inhalation and massage, while the control group receives carrier oil with the same massage protocol. Outcomes are assessed at baseline and during follow-up using ultrasonographic measurements and patient-reported questionnaires.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof.

Study Record Dates

First Submitted

June 18, 2026

First Posted

June 24, 2026

Study Start

September 2, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

July 2, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be made publicly available due to participant privacy considerations and institutional data protection policies.

Locations