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

Summary

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.

Conditions

• Dental Caries

Interventions

DEVICE

Ozone treatment

Ozone treatment applied to randomly selected tooth for a period of 60 seconds at Baseline, Three, Six and Nine-Month visits.

DEVICE

Placebo treatment

Placebo treatment applied to randomly selected tooth for a period of 60 seconds at Baseline, Three-, Six- and Nine-Month visits.

Sponsors & Collaborators

• Tufts University School of Dental Medicine

  collaborator OTHER

• State University of New York at Buffalo

  collaborator OTHER

• Indiana University

  lead OTHER

Principal Investigators

• Domenick T Zero, DDS MS · Indiana University

• Athena Papas, DMD, PhD · Tufts University School of Dental Medicine

• Sebastian Ciancio, DDS, PhD · SUNY School of Dental Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-02-28

Primary Completion

2009-05-31

Completion

2009-12-31

Countries

• United States

Study Locations