Ozone Therapy for Masticatory Muscle Pain (OTMMP)

Temporomandibular Joint Disorders Clinical Trial

— OTMMP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02997410
• Other study ID #: TCelakil
• Status: Active, not recruiting
• Phase: N/A
• First received: December 13, 2016
• Last updated: June 15, 2017
• Start date: December 2014
• Est. completion date: October 2017

Study information

• Verified date: June 2017
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: October 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Facial Pain
• Joint Diseases
• Myalgia
• Orofacial Pain
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Device:
• Ozone

• Placebo (for Ozone)

• Dental treatment with occlusal splint

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

References & Publications (2)

Daif ET. Role of intra-articular ozone gas injection in the management of internal derangement of the temporomandibular joint. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Jun;113(6):e10-4. doi: 10.1016/j.tripleo.2011.08.006. Epub 2012 Feb 28. — View Citation

Dogan M, Ozdemir Dogan D, Düger C, Ozdemir Kol I, Akpinar A, Mutaf B, Akar T. Effects of high-frequency bio-oxidative ozone therapy in temporomandibular disorder-related pain. Med Princ Pract. 2014;23(6):507-10. doi: 10.1159/000365355. Epub 2014 Sep 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline Pain Values (kg/cm2) at 1 month
Primary	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.	Change from Baseline Pain Values (kg/cm2) at 3 months
Primary	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.	Change from Baseline Pain Scores at 1 month
Primary	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.	Change from Baseline Pain Scores at 3 months
Secondary	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.	Baseline, 1 month and 3 months