TMDNCT05660343
Ozonated Olive Oil and Low-Level Laser Therapy in TMD Treatment
A study testing Ozonized Olive Oil Solutions and Low Level Laser LLL Therapy in people with TMD, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- TMD
- What is being tested?
- Ozonized Olive Oil Solutions and Low Level Laser LLL Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jun 2020to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
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- 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,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- TMD
- Being tested
- Ozonized Olive Oil Solutions, Low Level Laser LLL Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozonized Olive Oil SolutionsDrug
(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 TherapyDevice
(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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Ozonized Olive Oil Solutions; Device: Low Level Laser LLL Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Post-treatment (after 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start17 Jun 2020
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, levent Cigerim, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660343
- Sponsor's protocol ID
- 17.06.2020/18
- Status last verified
- Dec 2022
- First submitted
- 12 Dec 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Ozonated Olive Oil and Low-Level Laser Therapy in the Treatment of Pain in Individuals With Temporomandibular Disorder
- ClinicalTrials.gov ID
- NCT05660343
- Acronym / sponsor ID
- 17.06.2020/18
- Conditions
- TMD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozonated olive oil | Experimental | 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, 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. |
| Ozonated olive oil with low level laser therapy | Experimental | Drug: Ozonized Olive Oil Solutions, Device: Low Level Laser LLL 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Ozonated olive oil, Ozonated olive oil with low level laser therapy |
| 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 | Device | Ozonated olive oil with low level laser therapy |
Primary outcome
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).
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozonized Olive Oil Solutions and Low Level Laser LLL Therapy in people with TMD, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Evaluation (time frame: Pre-treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.