Temporomandibular joint dysfunction (TMJD) associated with chronic orofacial pain Oral Health
Conditions
Interventions
Current interventions as of 06/03/2026:
Participants were randomly assigned to four groups: a hydrogel containing geranium essential oil (H-GEO), a hydrogel containing lavender essential oil (H-LEO),
the pharmacist assigns the next code and dispenses identically packaged interventions.
The trial will be double-blind (participants, investigators, outcome assessors). The randomisation list will be
Sponsors
"Dunarea de Jos" University of Galati
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 06/03/2026: 1. Diagnosed temporomandibular joint dysfunction (TMJD) according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) criteria 2. Aged between 18 and 65 years 3. Chronic TMJ-related pain lasting more than 3 months 4. Baseline pain intensity =3 on the Visual Analog Scale (VAS). 5. Ability to comply with treatment and follow-up visits 6. Signed informed consent Previous key inclusion criteria: 1. Diagnosed temporomandibular joint dysfunction (TMJD) according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) criteria 2. Aged between 18 and 65 years 3. Chronic TMJ-related pain lasting more than 3 months 4. Baseline visual analogue scale (VAS) pain score =4/10 5. Ability to comply with treatment and follow-up visits 6. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Previous TMJ surgery 2. Acute infection or trauma of the TMJ area 3. Systemic rheumatologic or autoimmune disorders in active phase 4. Pregnancy or breastfeeding 5. Known allergy to essential oils or hydrogel components 6. Concurrent use of systemic corticosteroids or NSAIDs during trial period 7. Psychiatric or neurological conditions impairing protocol adherence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome as of 06/03/2026: Pain intensity measured using the Visual Analog Scale (VAS) at baseline (T0), 1 week (T1), 1 month (T2), 3 months (T3) Previous primary outcome: Pain intensity measured using the Visual Analog Scale (VAS) at baseline (T0), month 1 (T1), month 2 (T2), and month 3 (T3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline (T0), month 1 (T1), month 2 (T2), and month 3 (T3): 1. Maximum mouth opening (MMO) measured as part of the modified Helkimo Index using a digital Vernier caliper, recorded as the interincisal distance (mm) between the upper and lower central incisors. MMO values were then scored according to the modified Helkimo scale. 2. Muscle tenderness on palpation is assessed by common bilateral palpation of the masseter, temporalis, medial pterygoid, and other TMJ-associated muscles using approximately 1 kg/cm² of pressure, applied with the fingertips. The number of painful sites is then scored according to the modified Helkimo Index severity scale. 3. TMJ sounds (clicking, crepitus) and mandibular deviation are evaluated through direct clinical observation during mouth opening and closing, following the protocol used in the modified Helkimo Index. The presence or absence of deviation/sounds, as well as locking or dislocation, determines the score. 4. Patient-reported quality of life and functional impairment are assessed using a structured questionnaire based on the anamnestic (AnI) component of the modified Helkimo Index, which evaluates jaw-related discomfort, pain during function, stiffness, and the effect of symptoms on daily activities. 5. Adverse events are monitored continuously throughout the study and documented at each follow-up visit. Any unexpected reactions (e.g., skin irritation or discomfort) are recorded and, if necessary, reported to the safety protocol. | — |
Countries
Romania
Contacts
Public ContactDorin Ioan Coco?
Outcome results
None listed