Orofacial PainOTMMPNCT02997410
Ozone Therapy for Masticatory Muscle Pain (OTMMP)
A study testing Ozone and Dental treatment with occlusal splint in people with Orofacial Pain and Temporomandibular Joint Disorders, run by Istanbul University.
Trial summary
This study investigates the efficacy of bio-oxidative ozone application in the treatment of TMD of muscular origin. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Orofacial Pain, Temporomandibular Joint Disorders
- What is being tested?
- Ozone and Dental treatment with occlusal splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Oct 2017
- 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of myofascial pain according to the Research Diagnostic Criteria for Temporomandibular Disorder (RDC/TMD)
- Natural posterior occlusion.
Who cannot join
- Any TMJ internal derangement
- Inflammatory connective tissue disease
- Psychiatric problem
- Tumour
- Hearth disease or pacemaker
- Pregnancy
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- Other orofacial region disease symptoms (e.g. toothache, neuralgia, migraine)
- Treatment or medication use for headache or bruxism in the last 2 years
- Local skin infection over the masseter or temporal muscle
About this study
Official title: Effect of High-frequency Bio-oxidative Ozone Therapy for Masticatory Muscle Pain: a Double-blind Randomized Clinical Trial
This study investigates the efficacy of bio-oxidative ozone application in the treatment of TMD of muscular origin.
Read the detailed description
Ozone is a natural pale blue gas that can be found in the atmosphere. Medical grade ozone is a powerful oxidizing agent which can be produced commercially in ozone generators. Ozone can have effects on blood components and positively affect oxygen metabolism, cell energy, immunomodulation and microcirculation.
- Conditions
- Orofacial Pain, Temporomandibular Joint Disorders
- Being tested
- Ozone, Placebo (for Ozone), Dental treatment with occlusal splint
- Keywords
- Ozone
- Medical subject headings
- Facial Pain, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzoneDevice
Also called OzonytroneX
Placebo (for Ozone)Device
Dental treatment with occlusal splintDevice
| Study group | Role | What they receive |
|---|---|---|
| Ozone | Experimental | Ozone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks Receives: Device: Ozone |
| Placebo | Placebo comparator | Sham ozone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks Receives: Device: Placebo (for Ozone) |
| Occlusal splint | Experimental | Occlusal splint use every night over a period of 4 weeks. Receives: Device: Dental treatment with occlusal splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pain Values (kg/cm2) on the Pressure pain threshold measurement (PPT) using a Pressure Algometry at 1 month
Patient-reported pain intensity data when the feeling of pressure become painful, at which time the pressure is stopped. Measurements were separated by 30-s rest periods.
Measured: Change from Baseline Pain Values (kg/cm2) at 1 month
Change From Baseline in Pain Values (kg/cm2) on the Pressure pain threshold measurement (PPT) using a Pressure Algometry at 3 months
Patient-reported pain intensity data when the feeling of pressure become painful, at which time the pressure is stopped. Measurements were separated by 30-s rest periods.
Measured: Change from Baseline Pain Values (kg/cm2) at 3 months
Change From Baseline in Pain Scores on the Visual Analog Scale at 1 month
The measurement of subjective pain intensity is done using a 100-mm visual analogue scale.
Measured: Change from Baseline Pain Scores at 1 month
Change From Baseline in Pain Scores on the Visual Analog Scale at 3 months
The measurement of subjective pain intensity is done using a 100-mm visual analogue scale.
Measured: Change from Baseline Pain Scores at 3 months
Secondary outcomes (1)
Functional examination
Functional examination is based on Research Diagnostic Criteria for Temporomandibular Disorder (RDC/TMD) including extra-oral and cervical muscle pains, joint pains, mouth openings, lateral excursions and protrusion. Vertical and horizontal movements are measured with a plastic millimetre-scale ruler. Participants are asked to report any pain during muscle and joint palpation, and this information is recorded using a verbal scale: 0, no pain; 1, mild pain; 2, moderate pain; and 3, severe pain.
Measured: Baseline, 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startDec 2014
- Primary completionJun 2017
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Orofacial PainStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Celakil, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997410
- Sponsor's protocol ID
- TCelakil
- Acronym
- OTMMP
- Status last verified
- Jun 2017
- First submitted
- 13 Dec 2016
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dogan M, Ozdemir Dogan D, Duger C, Ozdemir Kol I, Akpinar A, Mutaf B, Akar T. Effects of high-frequency bio-oxidative ozone therapy in temporomandibular disorder-related pain. Med Princ Pract. 2014;23(6):507-10. doi: 10.1159/000365355. Epub 2014 Sep 3.
PubMed 25196631Daif ET. Role of intra-articular ozone gas injection in the management of internal derangement of the temporomandibular joint. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Jun;113(6):e10-4. doi: 10.1016/j.tripleo.2011.08.006. Epub 2012 Feb 28.
PubMed 22677023
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-frequency Bio-oxidative Ozone Therapy for Masticatory Muscle Pain: a Double-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02997410
- Acronym / sponsor ID
- OTMMP / TCelakil
- Conditions
- Orofacial Pain, Temporomandibular Joint Disorders
- Keywords
- Ozone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Oct 2017 (estimated)
- First posted
- 20 Dec 2016 (estimated)
- 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.
This study investigates the efficacy of bio-oxidative ozone application in the treatment of TMD of muscular origin.
Detailed description
Ozone is a natural pale blue gas that can be found in the atmosphere. Medical grade ozone is a powerful oxidizing agent which can be produced commercially in ozone generators. Ozone can have effects on blood components and positively affect oxygen metabolism, cell energy, immunomodulation and microcirculation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ozone | Experimental | Device: OzoneOzone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks |
| Placebo | Placebo comparator | Device: Placebo (for Ozone)Sham ozone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks |
| Occlusal splint | Experimental | Device: Dental treatment with occlusal splintOcclusal splint use every night over a period of 4 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of myofascial pain according to the Research Diagnostic Criteria for Temporomandibular Disorder (RDC/TMD)
- Natural posterior occlusion.
Key exclusion criteria (9 listed)
- Any TMJ internal derangement
- Inflammatory connective tissue disease
- Psychiatric problem
- Tumour
- Hearth disease or pacemaker
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 |
|---|---|---|
| OzoneAlso: OzonytroneX | Device | Ozone |
| Placebo (for Ozone) | Device | Placebo |
| Dental treatment with occlusal splint | Device | Occlusal splint |
Primary outcome
Change From Baseline in Pain Values (kg/cm2) on the Pressure pain threshold measurement (PPT) using a Pressure Algometry at 1 month
Time frame: Change from Baseline Pain Values (kg/cm2) at 1 month
Patient-reported pain intensity data when the feeling of pressure become painful, at which time the pressure is stopped. Measurements were separated by 30-s rest periods.
Change From Baseline in Pain Values (kg/cm2) on the Pressure pain threshold measurement (PPT) using a Pressure Algometry at 3 months
Time frame: Change from Baseline Pain Values (kg/cm2) at 3 months
Patient-reported pain intensity data when the feeling of pressure become painful, at which time the pressure is stopped. Measurements were separated by 30-s rest periods.
Change From Baseline in Pain Scores on the Visual Analog Scale at 1 month
Time frame: Change from Baseline Pain Scores at 1 month
The measurement of subjective pain intensity is done using a 100-mm visual analogue scale.
Change From Baseline in Pain Scores on the Visual Analog Scale at 3 months
Time frame: Change from Baseline Pain Scores at 3 months
The measurement of subjective pain intensity is done using a 100-mm visual analogue scale.
1 secondary outcome
Functional examination
Time frame: Baseline, 1 month and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Background: PubMed 25196631Dogan M, Ozdemir Dogan D, Duger C, Ozdemir Kol I, Akpinar A, Mutaf B, Akar T. Effects of high-frequency bio-oxidative ozone therapy in temporomandibular disorder-related pain. Med Princ Pract. 2014;23(6):507-10. doi: 10.1159/000365355. Epub 2014 Sep 3.
- Background: PubMed 22677023Daif ET. Role of intra-articular ozone gas injection in the management of internal derangement of the temporomandibular joint. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Jun;113(6):e10-4. doi: 10.1016/j.tripleo.2011.08.006. Epub 2012 Feb 28.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ozone and Dental treatment with occlusal splint in people with Orofacial Pain and Temporomandibular Joint Disorders, run by Istanbul University.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Change From Baseline in Pain Values (kg/cm2) on the Pressure pain threshold measurement (PPT) using a Pressure Algometry at 1 month (time frame: Change from Baseline Pain Values (kg/cm2) at 1 month). 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?
On the ClinicalTrials.gov record for NCT02997410, which also lists 2 linked publications.
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 16 Jun 2017.