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This study investigates the efficacy of bio-oxidative ozone application in the treatment of TMD of muscular origin.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozone | Experimental | Ozone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks |
|
| Placebo | Placebo Comparator | Sham ozone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks |
|
| Occlusal splint | Experimental | Occlusal splint use every night over a period of 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozone | Device |
|
| |
| Placebo (for Ozone) |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25196631 | Background | 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. | |
| 22677023 | Background | Daif 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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| ID | Term |
|---|---|
| D005157 | Facial Pain |
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003729 | Dental Care |
| D017090 | Occlusal Splints |
| ID | Term |
|---|---|
| D003813 | Dentistry |
| D003752 | Dental Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Device |
|
| Dental treatment with occlusal splint | Device |
|
| Baseline, 1 month and 3 months |
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |