Skip to main content
OpenTrials
Completed

NCT Number: NCT05660343

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

TMD

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Van Yüzüncü Yıl University

Van, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals aged 18 and over,
  • Individuals should be literate so that they can evaluate the consent form themselves,
  • Individuals with no restrictions to the use of any medication to be prescribed during the study,
  • Individuals who have not been treated for temporomandibular joint disease in the past 3 months,
  • Individuals who have not used any medication for the past two weeks,
  • Individuals who will participate in the study must be residing in the province of Van so that their regular records can be obtained,
  • Individuals without systemic disease,
  • Individuals with chronic pain, (pain that has been ongoing and lasted longer than six months),
  • Individuals with bilateral pain complaints,
  • Individuals without missing teeth,
  • Individuals without open bite and/or crossbite,

Exclusion criteria

  • Individuals with internal disorders and/or inflammatory joint disorders and/or joint's sound, 25
  • Individuals who have undergone interventional or surgical procedures on the Temporomandibular joint,
  • Individuals with temporomandibular joint pathology,
  • Individuals with the possibility of either being pregnant, are pregnant or lactating,
  • Individuals who will not attend postoperative check-ups,
  • Individuals using drugs other than those recommended,
  • Individuals who are allergic to any of the drugs and materials to be used throughout the study,
  • Individuals with contraindications to Ozone or Laser therapy.

Treatment and study plan

Ozonized Olive Oil Solutions

Drug

(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.

Low Level Laser LLL Therapy

Device

(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

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 21, 2022
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.