Ozone Therapy for Masticatory Muscle Pain (OTMMP)

Not Applicable

• Conditions: Temporomandibular Joint Disorders; Orofacial Pain
• Interventions: Device: Placebo (for Ozone); Device: Dental treatment with occlusal splint; Device: Ozone

• Registration Number: NCT02997410
• Lead Sponsor: Istanbul University

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2016-12-15
• Study First Posted: 2016-12-20
• Status Verified: 2017-06
• Primary Completion: 2017-06
• Last Update Submitted: 2017-06-15
• Last Update Posted: 2017-06-16
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (for Ozone)	Sham ozone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks
Occlusal splint	Dental treatment with occlusal splint	Occlusal splint use every night over a period of 4 weeks.
Ozone	Ozone	Ozone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Pain Values (kg/cm2) on the Pressure pain threshold measurement (PPT) using a Pressure Algometry at 1 month	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 in Pain Values (kg/cm2) on the Pressure pain threshold measurement (PPT) using a Pressure Algometry at 3 months	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 in Pain Scores on the Visual Analog Scale at 1 month	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 in Pain Scores on the Visual Analog Scale at 3 months	Change from Baseline Pain Scores at 3 months	The measurement of subjective pain intensity is done using a 100-mm visual analogue scale.

Secondary Outcome Measures

Name	Time	Method
Functional examination	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.