Ozone Therapy for Masticatory Muscle Pain (OTMMP)

NCT ID: NCT02997410

Last Updated: 2017-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Orofacial Pain Temporomandibular Joint Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ozone

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

Group Type EXPERIMENTAL

Ozone

Intervention Type DEVICE

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo (for Ozone)

Intervention Type DEVICE

Occlusal splint

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

Group Type EXPERIMENTAL

Dental treatment with occlusal splint

Intervention Type DEVICE

Interventions

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Ozone

Intervention Type DEVICE

Placebo (for Ozone)

Intervention Type DEVICE

Dental treatment with occlusal splint

Intervention Type DEVICE

Other Intervention Names

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OzonytroneX

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Tamer Celakil

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Dogan M, Ozdemir Dogan D, Duger 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.

Reference Type BACKGROUND
PMID: 25196631 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22677023 (View on PubMed)

Other Identifiers

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TCelakil

Identifier Type: -

Identifier Source: org_study_id

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