Ozone Therapy for Masticatory Muscle Pain (OTMMP) (OTMMP)

June 15, 2017 updated by: Tamer Celakil, Istanbul University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

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
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 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
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 Pain Values (kg/cm2) at 3 months
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 Pain Scores at 1 month
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.
Change from Baseline Pain Scores at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional examination
Time Frame: Baseline, 1 month and 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

June 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

December 13, 2016

First Submitted That Met QC Criteria

December 15, 2016

First Posted (Estimate)

December 20, 2016

Study Record Updates

Last Update Posted (Actual)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 15, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCelakil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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