Ozone Therapy for Masticatory Muscle Pain (OTMMP)

Study Overview
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Brief Summary
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This study investigates the efficacy of bio-oxidative ozone application in the treatment of TMD of muscular origin.

Detailed Description
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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.

Official Title
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Effect of High-frequency Bio-oxidative Ozone Therapy for Masticatory Muscle Pain: a Double-blind Randomized Clinical Trial

Conditions
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Orofacial Pain, Temporomandibular Joint Disorders

Intervention / Treatment
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* Device: Ozone
* Device: Placebo (for Ozone)
* Device: Dental treatment with occlusal splint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of myofascial pain according to the Research Diagnostic Criteria for Temporomandibular Disorder (RDC/TMD) Natural posterior occlusion. Exclusion Criteria: Any TMJ internal derangement Inflammatory connective tissue disease Psychiatric problem Tumour Hearth disease or pacemaker Pregnancy 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ozone<br>Ozone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks | Device: Ozone<br> <br> * Other names: OzonytroneX;|
| Placebo Comparator: Placebo<br>Sham ozone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks | Device: Placebo (for Ozone)<br> <br> |
| Experimental: Occlusal splint<br>Occlusal splint use every night over a period of 4 weeks. | Device: Dental treatment with occlusal splint<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Change from Baseline Pain Scores at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 1 month and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ozone