TMD
Conditions
Brief summary
The aim of the present study was to determine the efficacy of ozonated olive oil and low-level laser therapy (LLLT) in treating pain in individuals with TMD. In this prospective, randomized, split-mouth, double-blind study, two different treatment methods were applied to the patients.
Detailed description
two different treatment methods were applied to the patients. Group 1 (study group, one side of the same patient): topical ozonated olive oil + LLLT; Group 2 (the other side of the same patient): Olive oil with topical ozone + LLLT (not activated). The ozonated olive oil was applied topically three times a day for four weeks, the LLLT was applied noncontact at a distance of 1 cm, and patients attended three sessions per week for four weeks. Before starting treatment, and after 6 sessions of laser therapy, the patients were evaluated. (2 weeks), after 12 laser sessions (1 month), and 3 months after the first session.
Interventions
DRUGOzonized Olive Oil Solutions
(0.03PPM ozone + 6-6.5 PH olive oil, viscosity at 25°C 55mPas, relative density gr/ml (20°C) 0.98 pycnometer, 100 ml bottle.
DEVICELow Level Laser LLL Therapy
(0.03PPM ozone + 6-6.5 PH olive oil, viscosity at 25°C 55mPas, relative density gr/ml (20°C) 0.98 pycnometer, Ozonated olive oil, 100 ml bottle, and 810 nm diode laser, 3.4 j/cm2 energy density, 0.5w power, CHEESE DEN7A/DEN4A 810, 2 min for each side
Sponsors
Yuzuncu Yil University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
In order to apply the principle of double-blind, we ensure that neither the laser therapist nor the patient knew whether the treatment was active or not, classical music was played in the background to mask the laser sound and the laser's programs were arranged by an assistant so that the treatment did not begin until a permission was taken from the assistant; in addition, labels on Oil bottles were removed by an assistant to ensure that no one knew the type of the Oil or its ingredients. For safety reasons, both the patient and the laser therapist wore protective goggles during the laser treatment. All patients were treated with ozonated olive oil and LLL by the same therapist.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Individuals aged 18 and over, 2. Individuals should be literate so that they can evaluate the consent form themselves, 3. Individuals with no restrictions to the use of any medication to be prescribed during the study, 4. Individuals who have not been treated for temporomandibular joint disease in the past 3 months, 5. Individuals who have not used any medication for the past two weeks, 6. Individuals who will participate in the study must be residing in the province of Van so that their regular records can be obtained, 7. Individuals without systemic disease, 8. Individuals with chronic pain, (pain that has been ongoing and lasted longer than six months), 9. Individuals with bilateral pain complaints, 10. Individuals without missing teeth, 11. Individuals without open bite and/or crossbite,
Exclusion criteria
1. Individuals with internal disorders and/or inflammatory joint disorders and/or joint's sound, 25 2. Individuals who have undergone interventional or surgical procedures on the Temporomandibular joint, 3. Individuals with temporomandibular joint pathology, 4. Individuals with the possibility of either being pregnant, are pregnant or lactating, 5. Individuals who will not attend postoperative check-ups, 6. Individuals using drugs other than those recommended, 7. Individuals who are allergic to any of the drugs and materials to be used throughout the study, 8. Individuals with contraindications to Ozone or Laser therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Evaluation | Pre-treatment | Patients will be requested to mark their pain intensity on a pain assessment form using a visual analog scale (VAS) ranging between 0 (no pain) to 10 (most severe pain). |
Countries
Turkey (Türkiye)
Outcome results
None listed