Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00495495
Status:
COMPLETED
Last Update Posted:
2015-02-20
First Post:
2007-07-01
Brief Title:
Healozone Study to Evaluate the Safety and Efficacy of the Use of Ozone for Management of Dental Caries
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
A Multi-Center Study to Evaluate the Safety and Efficacy of the Use of Ozone for the Management of Fissure Caries
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
The proposed study was designed as a twelve-month multi-center double-blind randomized controlled clinical study involving 394 subjects with 788 lesions There were three sites participating in this trial Indiana University School of Dentistry lead site Tufts University School of Dental Medicine and SUNY School of Dental Medicine Each site submitted a version of the protocol to their respective Institutional Review Board IRB that incorporated the specific institutional and state guidelines and regulations applicable to that site
The two treatment regimens were a placebo treatment and b experimental ozone treatment Selected subjects had to have at least two teeth with similar stages of early active fissure caries The selection of the study teeth was determined by a review of the visual examination including the ICDAS severity score and the caries lesion activity score conducted at the screening visit in conjunction with the bitewing radiographs The decision whether a tooth was to be treated with ozone or receive placebo treatment was made randomly
All clinical personnel involved in the clinical examinations and treatment application were trained at the primary site prior to the initiation of the trial both in the use of the device and in how to identify the signs and symptoms of ozone toxicity and in how to provide the appropriate medical response should any of these signs or symptoms be observed
All qualified subjects received the following
1 Professional dental cleaning and scaling at the Screening Visit or separate visit prior to baseline visit and after completing the study at 12 months
2 Diagnostic procedures
1 Clinical visual examination utilizing the International Caries Detection and Assessment System ICDAS severity scoring
2 Clinical visualtactile assessment of caries lesion activity
3 Bitewing x-rays
4 Laser fluorescence measurement utilizing the DIAGNOdent KaVo
3 Treatment Regimen
Using a split-mouth design the assigned investigational treatment regimen was administered on the two selected study teeth at the baseline and at the three- six- and nine-month appointments
After three six nine and twelve months the diagnostic procedures were repeated with the exception of bitewing x-rays which were only repeated at the twelve-month exam unless the examining dentist determined that x-rays also were needed at the six- or nine-month visit to confirm whether dentinal caries were present In addition optional digital photographs were taken at the Boston site of selected study teeth to document clinical changes over the study period
If a selected study tooth progressed from an initial caries lesion to a more advanced lesion which in the judgment of the examining dentist required restorative intervention the tooth was restored at no cost to the subject and the lesion was recorded as progression from baseline at any remaining examinations The subject was eligible to remain in the study
Subjects received a thorough dental cleaning and scaling and topical fluoride treatment at the conclusion of the twelve-month examination
The primary efficacy parameter will be the ICDAS severity value The severity criteria used in the ICDAS diagnostic system 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
The secondary efficacy parameters will be measured by
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 whitishyellowish opaque with loss of luster The surface feels rough when the tip of the probe is moved gently across the surface
Radiographic Changes
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 greaterpulpal exposure
Laser fluorescence measurement
DIAGNOdent reading using a scale from 00 to 99 with 00 indicating no caries activity and 99 indicating a high level of activity
The two treatment regimens were a placebo treatment and b experimental ozone treatment Selected subjects had to have at least two teeth with similar stages of early active fissure caries The selection of the study teeth was determined by a review of the visual examination including the ICDAS severity score and the caries lesion activity score conducted at the screening visit in conjunction with the bitewing radiographs The decision whether a tooth was to be treated with ozone or receive placebo treatment was made randomly
All clinical personnel involved in the clinical examinations and treatment application were trained at the primary site prior to the initiation of the trial both in the use of the device and in how to identify the signs and symptoms of ozone toxicity and in how to provide the appropriate medical response should any of these signs or symptoms be observed
All qualified subjects received the following
1 Professional dental cleaning and scaling at the Screening Visit or separate visit prior to baseline visit and after completing the study at 12 months
2 Diagnostic procedures
1 Clinical visual examination utilizing the International Caries Detection and Assessment System ICDAS severity scoring
2 Clinical visualtactile assessment of caries lesion activity
3 Bitewing x-rays
4 Laser fluorescence measurement utilizing the DIAGNOdent KaVo
3 Treatment Regimen
Using a split-mouth design the assigned investigational treatment regimen was administered on the two selected study teeth at the baseline and at the three- six- and nine-month appointments
After three six nine and twelve months the diagnostic procedures were repeated with the exception of bitewing x-rays which were only repeated at the twelve-month exam unless the examining dentist determined that x-rays also were needed at the six- or nine-month visit to confirm whether dentinal caries were present In addition optional digital photographs were taken at the Boston site of selected study teeth to document clinical changes over the study period
If a selected study tooth progressed from an initial caries lesion to a more advanced lesion which in the judgment of the examining dentist required restorative intervention the tooth was restored at no cost to the subject and the lesion was recorded as progression from baseline at any remaining examinations The subject was eligible to remain in the study
Subjects received a thorough dental cleaning and scaling and topical fluoride treatment at the conclusion of the twelve-month examination
The primary efficacy parameter will be the ICDAS severity value The severity criteria used in the ICDAS diagnostic system 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
The secondary efficacy parameters will be measured by
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 whitishyellowish opaque with loss of luster The surface feels rough when the tip of the probe is moved gently across the surface
Radiographic Changes
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 greaterpulpal exposure
Laser fluorescence measurement
DIAGNOdent reading using a scale from 00 to 99 with 00 indicating no caries activity and 99 indicating a high level of activity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Clinical Trials gov | REGISTRY | ClinicalTrialsgov protocol registration system | None |
| IDE G50008 | None | None | None |