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NCT00495495 · ClinicalTrials.gov registry record · Phase 2
Healozone Study to Evaluate the Safety and Efficacy of the Use of Ozone for Management of Dental Caries
A Phase 2 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 2
- Development phase
- 394
- Enrollment target
NCT00495495: Completed Phase 2 study, sponsored by Indiana University.
NCT00495495 is a Phase 2 study that has completed, run by Indiana University. The registered enrollment target is 394 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (196% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00495495, a Phase 2 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 394 participants
- Enrollment target
Study 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.
Primary Outcome
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 visib
Interventions
- DEVICE Ozone treatment
- DEVICE Placebo treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 394 participants |
| Start Date | 2007-02 |
| Est. Completion | 2009-12 |
| Phase | Phase 2 |
What the finished NCT00495495 record still lists
NCT00495495 is an interventional study that assigns participants to a tested intervention. The registered 394 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (196% higher).
The record links to 0 conditions, and to 2 interventions - of which Ozone treatment is the first listed.
NCT00495495 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00495495 about?
NCT00495495 is a clinical study titled "Healozone Study to Evaluate the Safety and Efficacy of the Use of Ozone for Management of Dental Caries". 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 e...
What is the current status of trial NCT00495495?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 394 participants. The study started on 2007-02. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00495495?
The interventions under investigation include: Ozone treatment (DEVICE), Placebo treatment (DEVICE).
Who is sponsoring clinical trial NCT00495495?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00495495's enrollment target sits among peer trials
394 103rd of 2000 higher than 1,897 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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