Ozone Therapy for Masticatory Muscle Pain (OTMMP)

Istanbul University

Status: Unknown

Conditions: Temporomandibular Joint Disorders; Orofacial Pain

Treatments: Device: Dental treatment with occlusal splint; Device: Ozone; Device: Placebo (for Ozone)

Study type: Interventional

Funder types: Other

Identifiers

NCT02997410

TCelakil

Details and patient eligibility

About

This study investigates the efficacy of bio-oxidative ozone application in the treatment of TMD of muscular origin.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Ozone

Experimental group

Description:

Ozone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks

Treatment:

Device: Ozone

Placebo

Placebo Comparator group

Description:

Sham ozone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks

Treatment:

Device: Placebo (for Ozone)

Occlusal splint

Experimental group

Description:

Occlusal splint use every night over a period of 4 weeks.

Treatment:

Device: Dental treatment with occlusal splint