Clinical trial NCT05660343: Ozonated Olive Oil and Low-Level Laser Therapy in TMD Treatment
Official title: Evaluation of the Efficacy of Ozonated Olive Oil and Low-Level Laser Therapy in the Treatment of Pain in Individuals With Temporomandibular Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TMD
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Evaluation
timeFrame: Pre-treatment
measure: Pain Evaluation
timeFrame: Post-treatment (after 2 weeks )
measure: Pain Evaluation
timeFrame: Post-treatment (after 1 month)
measure: Pain Evaluation
timeFrame: Post-treatment (after 3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Yüzüncü Yıl University
Study officials:
References: