NCT02997410

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

2.5 years

First QC Date

December 13, 2016

Last Update Submit

June 15, 2017

Conditions

Orofacial PainTemporomandibular Joint Disorders

Keywords

Ozone

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • Functional examination

    Baseline, 1 month and 3 months

Study Arms (3)

Ozone

EXPERIMENTAL

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

Device: Ozone

Placebo

PLACEBO COMPARATOR

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

Device: Placebo (for Ozone)

Occlusal splint

EXPERIMENTAL

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

Device: Dental treatment with occlusal splint

Interventions

OzoneDEVICE
Also known as: OzonytroneX
Ozone
Placebo (for Ozone)DEVICE
Placebo
Dental treatment with occlusal splintDEVICE
Occlusal splint

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of myofascial pain according to the Research Diagnostic Criteria for Temporomandibular Disorder (RDC/TMD)
  • Natural posterior occlusion.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 25196631BACKGROUND

  • 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.

    PMID: 22677023BACKGROUND

MeSH Terms

Conditions

Facial PainTemporomandibular Joint Disorders

Interventions

Dental CareOcclusal Splints

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

DentistryDental Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesOrthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

December 13, 2016

First Posted

December 20, 2016

Study Start

December 1, 2014

Primary Completion

June 1, 2017

Study Completion

October 1, 2017

Last Updated

June 16, 2017

Record last verified: 2017-06