Ozone Therapy for Masticatory Muscle Pain (OTMMP)

Effect of High-frequency Bio-oxidative Ozone Therapy for Masticatory Muscle Pain: a Double-blind Randomized Clinical Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02997410

Acronym

OTMMP

Enrollment

Registered

2016-12-20

Start date

2014-12-31

Completion date

2017-10-31

Last updated

2017-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orofacial Pain, Temporomandibular Joint Disorders

Keywords

Ozone

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.

Interventions

DEVICEOzone

DEVICEPlacebo (for Ozone)

DEVICEDental treatment with occlusal splint

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026