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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
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orofacial Pain focused on measuring Ozone

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    December 13, 2016
    Last Updated
    June 15, 2017
    Sponsor
    Istanbul University
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    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
    background
    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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