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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 is a Phase 2 study that has completed, run by Indiana University. The registered enrollment target is 394 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00495495
The ClinicalTrials.gov registry entry for NCT00495495 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 394 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ozone treatment is the first listed.
NCT00495495 reports 0 study locations.
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.
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