Ozone Therapy for Masticatory Muscle Pain (OTMMP) (OTMMP)
Primary Purpose
Orofacial Pain, Temporomandibular Joint Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ozone
Placebo (for Ozone)
Dental treatment with occlusal splint
Sponsored by
About this trial
This is an interventional treatment trial for Orofacial Pain focused on measuring Ozone
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
Ozone
Placebo
Occlusal splint
Arm Description
Ozone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks
Sham ozone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks
Occlusal splint use every night over a period of 4 weeks.
Outcomes
Primary Outcome Measures
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 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 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 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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02997410
Brief Title
Ozone Therapy for Masticatory Muscle Pain (OTMMP)
Acronym
OTMMP
Official Title
Effect of High-frequency Bio-oxidative Ozone Therapy for Masticatory Muscle Pain: a Double-blind Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orofacial Pain, Temporomandibular Joint Disorders
Keywords
Ozone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ozone
Arm Type
Experimental
Arm Description
Ozone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sham ozone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks
Arm Title
Occlusal splint
Arm Type
Experimental
Arm Description
Occlusal splint use every night over a period of 4 weeks.
Intervention Type
Device
Intervention Name(s)
Ozone
Other Intervention Name(s)
OzonytroneX
Intervention Type
Device
Intervention Name(s)
Placebo (for Ozone)
Intervention Type
Device
Intervention Name(s)
Dental treatment with occlusal splint
Primary Outcome Measure Information:
Title
Change From Baseline in Pain Values (kg/cm2) on the Pressure pain threshold measurement (PPT) using a Pressure Algometry at 1 month
Description
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.
Time Frame
Change from Baseline Pain Values (kg/cm2) at 1 month
Title
Change From Baseline in Pain Values (kg/cm2) on the Pressure pain threshold measurement (PPT) using a Pressure Algometry at 3 months
Description
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.
Time Frame
Change from Baseline Pain Values (kg/cm2) at 3 months
Title
Change From Baseline in Pain Scores on the Visual Analog Scale at 1 month
Description
The measurement of subjective pain intensity is done using a 100-mm visual analogue scale.
Time Frame
Change from Baseline Pain Scores at 1 month
Title
Change From Baseline in Pain Scores on the Visual Analog Scale at 3 months
Description
The measurement of subjective pain intensity is done using a 100-mm visual analogue scale.
Time Frame
Change from Baseline Pain Scores at 3 months
Secondary Outcome Measure Information:
Title
Functional examination
Description
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.
Time Frame
Baseline, 1 month and 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
25196631
Citation
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.
Results Reference
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PubMed Identifier
22677023
Citation
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.
Results Reference
background
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Ozone Therapy for Masticatory Muscle Pain (OTMMP)
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