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

NCT ID: NCT05660343

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-17

Study Completion Date

2021-03-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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TMD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Ozonized Olive Oil Solutions

Intervention Type 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 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.

Group Type EXPERIMENTAL

Ozonized Olive Oil Solutions

Intervention Type 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

Intervention Type 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

Interventions

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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.

Intervention Type DRUG

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yuzuncu Yıl University

OTHER

Sponsor Role lead

Responsible Party

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levent Cigerim

Head of oral and maxillofacial department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Van Yüzüncü Yıl University

Van, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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17.06.2020/18

Identifier Type: -

Identifier Source: org_study_id