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

December 20, 2022 updated by: levent Cigerim, Yuzuncu Yıl University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Van, Turkey
        • Van Yuzuncu Yıl University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Evaluation
Time Frame: 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).
Pre-treatment
Pain Evaluation
Time Frame: Post-treatment (after 2 weeks )
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
Time Frame: Post-treatment (after 1 month)
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
Time Frame: Post-treatment (after 3 months)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yuzuncu Yıl University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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