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

NCT05660343 | Completed

• 1 other identifier: 17.06.2020/18
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

TMD

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (2)

Ozonated olive oil

EXPERIMENTAL

(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

Ozonated olive oil with low level laser therapy

EXPERIMENTAL

(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; Device: Low Level Laser LLL Therapy

Interventions

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.

Ozonated olive oil; Ozonated olive oil with low level laser therapy

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

Ozonated olive oil with low level laser therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yüzüncü Yıl University

Van, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In order to apply the principle of double-blind, we ensure that neither the laser therapist nor the patient knew whether the treatment was active or not, classical music was played in the background to mask the laser sound and the laser's programs were arranged by an assistant so that the treatment did not begin until a permission was taken from the assistant; in addition, labels on Oil bottles were removed by an assistant to ensure that no one knew the type of the Oil or its ingredients. For safety reasons, both the patient and the laser therapist wore protective goggles during the laser treatment. All patients were treated with ozonated olive oil and LLL by the same therapist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of oral and maxillofacial department

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 21, 2022
• Study Start: June 17, 2020
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

TU (1)