Ozone Therapy for Masticatory Muscle Pain (OTMMP)

Istanbul University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Orofacial Pain Temporomandibular Joint Disorders

Interventions

OzoneDEVICE

Placebo (for Ozone)DEVICE

Dental treatment with occlusal splintDEVICE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Change from Baseline Pain Scores at 3 months

Secondary Outcomes

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.

Time frame: Baseline, 1 month and 3 months

Data from ClinicalTrials.gov

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