Ozonated Olive Oil and Low-Level Laser Therapy in TMD Treatment

TMD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05660343
• Other study ID #: 17.06.2020/18
• Status: Completed
• Phase: N/A
• Start date: June 17, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: December 2022
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• TMD

Intervention

Drug:
• Ozonized 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.

Device:
• Low 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

Locations

Country	Name	City	State
Turkey	Van Yüzüncü Yil University	Van

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Evaluation	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).	Pre-treatment
Primary	Pain Evaluation	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).	Post-treatment (after 2 weeks )
Primary	Pain Evaluation	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).	Post-treatment (after 1 month)
Primary	Pain Evaluation	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).	Post-treatment (after 3 months)