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

Evaluation of the Efficacy of Ozonated Olive Oil and Low-Level Laser Therapy in the Treatment of Pain in Individuals With Temporomandibular Disorder

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.

Study Overview

• Status: Completed
• Conditions: TMD
• Intervention / Treatment: Drug: Ozonized Olive Oil Solutions; Device: Low Level Laser LLL Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Van, Turkey
    • Van Yuzuncu Yıl University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ozonated olive oil; (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, Olive Farm, GÜLLERDAĞI TURİZM TARIM İNŞ), Ozonated Olive Oil is used 3 times a day, every day for four weeks. Patients were instructed to spray three times on each side. To ensure commitment, Oil canisters were marked in the middle, which the patient was required to use until the label in the first two weeks, and the remaining amount in the second two weeks.	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.
Experimental: Ozonated olive oil with low level laser therapy; (810 nm diode laser, 3.4 j/cm2 energy density, 0.5w power, CHEESE DEN7A/DEN4A 810, 2 min for each side) was applied non-contact at a distance of 1 cm, the most painful points in the muscles diagnosed during the first examination were irradiated with circular movements and patients were called for 3 sessions per week over four weeks.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 )
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)
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)

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2020
• Primary Completion (Actual): March 30, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 17.06.2020/18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No