Healozone Study to Evaluate the Safety and Efficacy of the Use of Ozone for Management of Dental Caries - Full Text View

Sponsor:	Indiana University School of Dentistry
Collaborators:	Tufts University State University of New York at Buffalo
Information provided by:	Indiana University School of Dentistry
ClinicalTrials.gov Identifier:	NCT00495495

Purpose

Caries means demineralization with the formation of cavities and pulp symptoms and necrosis as an end result. The acids in the mouth are mainly produced by oral bacteria like Streptococcus mutans from bacterial biofilms adhering to the tooth. Ozone has been shown to have a very strong bactericidal effect on bacteria causing dental caries. Baysan et al reported that there was a statistically significant reduction of streptococci in root caries lesions and saliva samples after ozone application. The positive clinical effect of ozone with respect to arresting caries progression and the remineralization of caries has been shown in vitro and in vivo. In an in vivo study, Baysan and Lynch found that the application of ozone resulted in a significant reduction of bacterial contamination as well as a reduction in size and severity of root caries lesions. In a subsequent study, Baysan and Lynch reported that the severity of root caries lesions was significantly reduced after ozone application as measured by electrical conductance and laser fluorescence. In several studies, the caries reducing effect of ozone was measured with biochemical methods in root surface caries lesions, the biofilm and saliva after ozone application. See Citation section for references.

The objectives of this multi-center clinical study were to determine: (1) the effectiveness of the HealOzone in stopping the progression of fissure caries; and (2) the oral soft tissue safety of the ozone system.

Condition	Intervention	Phase
Dental Caries	Device: Ozone treatment Device: Placebo treatment	Phase II Phase III

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
Official Title:	A Multi-Center Study to Evaluate the Safety and Efficacy of the Use of Ozone for the Management of Fissure Caries

Resource links provided by NLM:

MedlinePlus related topics: Ozone Tooth Decay

U.S. FDA Resources

Further study details as provided by Indiana University School of Dentistry:

Primary Outcome Measures:

ICDAS Severity Value [ Time Frame: Baseline and One Year ] [ Designated as safety issue: No ]
Clinically significant changes indicating caries progression are defined as changes in ICDAS severity values from 1 or 2 to a 3 or higher, or from a 3 or 4 to a 5 or higher. The severity criteria are as follows:

0 = Sound tooth surface.
1. = First visual change in enamel.
2. = Distinct visual change in enamel.
3. = Localized enamel breakdown due to caries with no visible dentin.
4. = Underlying dark shadow from dentin, with or without localized enamel breakdown.
5. = Distinct cavity with visible dentin.
6. = Extensive distinct cavity with visible dentin.

Secondary Outcome Measures:

Change in Caries Lesion Activity [ Time Frame: Baseline and one year ] [ Designated as safety issue: No ]
Change in caries lesion activity at One Year. All teeth were considered Active at Baseline

Caries Lesion Activity score:
1. = Inactive - surface of enamel appears whitish, brownish or black. Enamel may be shiny and feels hard and smooth when the tip of the probe is moved gently across the surface.
2. = Active lesion - surface of enamel appears whitish/yellowish opaque with loss of luster. The surface feels rough when the tip of the probe is moved gently across the surface.
Progression of Radiographic Scores at 12 Months [ Time Frame: one year ] [ Designated as safety issue: No ]
Clinically significant changes for Bitewing x-rays indicating caries progression would be changes in x-ray criterion for lesion presence from "no" to "yes" or for lesion depth to a D1 or higher. The occlusal surface of study teeth will be evaluated using the following scale:

Lesion presence: yes /no

Lesion depth:

E1 = outer half of enamel E2 = inner half of enamel D1 = outer third of dentin D2 = middle third of dentin D3 = inner third of dentin or greater/pulpal exposure
Laser Fluorescence Progression-12 Month (Increase From <=20 to >=30) [ Time Frame: one year ] [ Designated as safety issue: No ]
The change in DIAGNOdent measurements between baseline and twelve-month visits was used as an additional secondary endpoint. Clinically significant changes for DIAGNOdent indicating caries progression would be an increase in DIAGNOdent reading of 10 or more units or an increase in DIAGNOdent reading from below 20 to above 30 units. DIAGNOdent reading using a scale from 00 to 99, with 00 indicating no caries activity and 99 indicating a high level of activity.
Laser Fluorescence Progression-12 Month (Increase at Least 10) [ Time Frame: one year ] [ Designated as safety issue: No ]
The change in DIAGNOdent measurements between baseline and twelve-month visits was used as an additional secondary endpoint. Clinically significant changes for DIAGNOdent indicating caries progression would be an increase in DIAGNOdent reading of 10 or more units. DIAGNOdent reading using a scale from 00 to 99, with 00 indicating no caries activity and 99 indicating a high level of activity.

Enrollment:	394
Study Start Date:	February 2007
Study Completion Date:	December 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ozone treatment Ozone treatment of randomly selected study tooth for 60 seconds	Device: Ozone treatment Ozone treatment applied to randomly selected tooth for a period of 60 seconds at Baseline, Three, Six and Nine-Month visits. Other Name: HealOzone unit
Placebo Comparator: Placebo, no ozone Placebo treatment (no ozone) of randomly selected study tooth for 60 seconds.	Device: Placebo treatment Placebo treatment applied to randomly selected tooth for a period of 60 seconds at Baseline, Three-, Six- and Nine-Month visits.

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Eligibility

Ages Eligible for Study:	10 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

To be eligible for study participation, subjects had to:

1. provide written informed consent, HIPAA authorization and medical history information prior to their participation; 2. be between the ages of 10 and 40 years of age; 3. if female and of childbearing potential, agree to:

a urine pregnancy test, which must be negative;
use one form of medically accepted contraceptive measures which include oral contraceptives, condom, or diaphragm with spermicide, Intra Uterine Device (IUD), Depo-Provera, Norplant during the study and for at least 30 days after the last treatment. (Females who are post menopausal, i.e. amenorrhea for the previous 12 months, or surgically sterile may be included.) 4. be in good general health as evidenced by a review of the medical history; 5. have good oral health; 6. agree to comply with all subjects' responsibilities as stated in the protocol (e.g. attendance at appointments, turning off of cell phone during appointment, etc.); and 7. have two posterior (molar or premolar) teeth with active fissure caries as defined by ICDAS severity score between 1 and 4, a caries lesion activity score of 2, and with radiographic evidence indicating that there is no extension past the dentinal enamel junction. Lesions within the same subject ideally should have the same ICDAS criterion; however, the following deviations will be acceptable - teeth with ICDAS criterion 1 paired with a 2, and a 3 paired with a 4.

Exclusion Criteria:

Any of the following excluded subjects from participating:

a medical condition that requires antibiotic therapy prior to dental work;
any medical condition that could be expected to interfere with the subject's safety, such as a pacemaker or similar powered implant;
selected study teeth with occlusal restorations, sealants, carious lesions extending into dentin, hypomineralization or fluorosis;
generalized severe gingivitis or gross unrestored caries;
orthodontic appliances that interfere with access to selected study teeth;
pregnant or nursing.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495495

Locations

United States, Indiana
Indiana University School of Dentistry
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Tufts University School of Dental Medicine
Boston, Massachusetts, United States, 02111
United States, New York
State University of New York at Buffalo, School of Dental Medicine
Buffalo, New York, United States, 14214

Sponsors and Collaborators

Indiana University School of Dentistry

Tufts University

State University of New York at Buffalo

Investigators

Principal Investigator:	Domenick T Zero, DDS MS	Indiana University School of Dentistry
Principal Investigator:	Athena Papas, DMD, PhD	Tufts University
Principal Investigator:	Sebastian Ciancio, DDS, PhD	SUNY School of Dental Medicine

More Information

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

Additional relevant MeSH terms:

Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on February 09, 2012