Healozone Study to Evaluate the Safety and Efficacy of the Use of Ozone for Management of Dental Caries
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|ClinicalTrials.gov Identifier: NCT00495495|
Recruitment Status : Completed
First Posted : July 3, 2007
Results First Posted : December 23, 2010
Last Update Posted : February 20, 2015
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 or disease||Intervention/treatment||Phase|
|Dental Caries||Device: Ozone treatment Device: Placebo treatment||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||394 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Multi-Center Study to Evaluate the Safety and Efficacy of the Use of Ozone for the Management of Fissure Caries|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||December 2009|
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.
- ICDAS Severity Value [ Time Frame: Baseline and One Year ]
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.
- = First visual change in enamel.
- = Distinct visual change in enamel.
- = Localized enamel breakdown due to caries with no visible dentin.
- = Underlying dark shadow from dentin, with or without localized enamel breakdown.
- = Distinct cavity with visible dentin.
- = Extensive distinct cavity with visible dentin.
- Change in Caries Lesion Activity [ Time Frame: Baseline and one year ]
Change in caries lesion activity at One Year. All teeth were considered Active at Baseline
Caries Lesion Activity score:
- = 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.
- = 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 ]
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
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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495495
|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|
|Principal Investigator:||Domenick T Zero, DDS MS||Indiana University|
|Principal Investigator:||Athena Papas, DMD, PhD||Tufts University School of Dental Medicine|
|Principal Investigator:||Sebastian Ciancio, DDS, PhD||SUNY School of Dental Medicine|