Healozone Study to Evaluate the Safety and Efficacy of the Use of Ozone for Management of Dental Caries

This study has been completed.

Study NCT00495495 Information provided by Indiana University School of Dentistry

First Received on July 1, 2007. Last Updated on January 5, 2011 History of Changes

Results First Received: October 12, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Dental Caries
Interventions:	Device: Ozone treatment Device: Placebo treatment

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Ozone Treatment and Placebo Treatment	60-second Ozone device treatment compared to 60-second Placebo device treatment. Study utilized split-mouth design. The paired treatment assignment for the two teeth within each subject was performed according to a randomization table provided by the Biometrician. Randomization of teeth to Ozone treatment or Placebo treatment was stratifed according to tooth similarity.

Participant Flow: Overall Study

	Ozone Treatment and Placebo Treatment
STARTED	394
COMPLETED	295
NOT COMPLETED	99
Protocol Violation	99

Baseline Characteristics

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Reporting Groups

	Description
Ozone Treatment/Placebo Treatment	Study utilized split-mouth design. Each participant had two teeth selected at the start of the study. Each participant was then randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds and Placebo treatment on a randomly selected study tooth for 60 seconds.

Baseline Measures

	Ozone Treatment/Placebo Treatment
Number of Participants [units: participants]	394
Age [units: participants]
<=18 years	102
Between 18 and 65 years	292
>=65 years	0
Age [units: years] Mean ± Standard Deviation	22.9 ± 7.2
Gender [units: participants]
Female	202
Male	192
Region of Enrollment [units: participants]
United States	394

Outcome Measures

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1. Primary:

ICDAS Severity Value [ Time Frame: Baseline and One Year ]

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2. Secondary:

Change in Caries Lesion Activity [ Time Frame: Baseline and one year ]

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3. Secondary:

Progression of Radiographic Scores at 12 Months [ Time Frame: one year ]

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4. Secondary:

Laser Fluorescence Progression-12 Month (Increase From <=20 to >=30) [ Time Frame: one year ]

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5. Secondary:

Laser Fluorescence Progression-12 Month (Increase at Least 10) [ Time Frame: one year ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study length may have been too brief to permit progression of early stage caries; Low caries increment in study population; Difficult to establish that lesions were truly active at baseline.

Results Point of Contact:

Name/Title: Domenick T. Zero, DDS MS Principal Investigator
Organization: Indiana University School of Dentistry
phone: 317-274-8822
e-mail: dzero@iupui.edu

No publications provided

Responsible Party:	Dr. Domenick Zero, Indiana University School of Dentistry
ClinicalTrials.gov Identifier:	NCT00495495 History of Changes
Other Study ID Numbers:	07-D-187, IDE G50008, Clinical Trials. gov
Study First Received:	July 1, 2007
Results First Received:	October 12, 2010
Last Updated:	January 5, 2011
Health Authority:	United States: Food and Drug Administration