A Multi-Center Study to Evaluate the Safety and Efficacy of the Use of Ozone for the Management of Fissure Caries
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 394
- Locations
- 6
- Primary Endpoint
- ICDAS Severity Value
Study Overview
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.
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:
- Professional dental cleaning and scaling at the Screening Visit (or separate visit prior to baseline visit and after completing the study at 12 months.
- Diagnostic procedures:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 10 Years to 40 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •To be eligible for study participation, subjects had to:
- •provide written informed consent, HIPAA authorization and medical history information prior to their participation;
- •be between the ages of 10 and 40 years of age;
- •if female and of childbearing potential, agree to:
- •a urine pregnancy test, which must be negative;
- •use one form of medically accepted contraceptive measures which include oral contraceptives, condom, or diaphragm with spermicide, Intra Uterine Device (IUD), Depo-Provera, Norplant during the study and for at least 30 days after the last treatment. (Females who are post menopausal, i.e. amenorrhea for the previous 12 months, or surgically sterile may be included.)
- •be in good general health as evidenced by a review of the medical history;
- •have good oral health;
- •agree to comply with all subjects' responsibilities as stated in the protocol (e.g. attendance at appointments, turning off of cell phone during appointment, etc.); and
- •have two posterior (molar or premolar) teeth with active fissure caries as defined by ICDAS severity score between 1 and 4, a caries lesion activity score of 2, and with radiographic evidence indicating that there is no extension past the dentinal enamel junction. Lesions within the same subject ideally should have the same ICDAS criterion; however, the following deviations will be acceptable - teeth with ICDAS criterion 1 paired with a 2, and a 3 paired with a 4.
Exclusion Criteria
- •Any of the following excluded subjects from participating:
- •a medical condition that requires antibiotic therapy prior to dental work;
- •any medical condition that could be expected to interfere with the subject's safety, such as a pacemaker or similar powered implant;
- •selected study teeth with occlusal restorations, sealants, carious lesions extending into dentin, hypomineralization or fluorosis;
- •generalized severe gingivitis or gross unrestored caries;
- •orthodontic appliances that interfere with access to selected study teeth;
- •pregnant or nursing.
Outcomes
Primary Outcomes
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. 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.
Secondary Outcomes
- Change in Caries Lesion Activity(Baseline and one year)
- Progression of Radiographic Scores at 12 Months(one year)
- Laser Fluorescence Progression-12 Month (Increase From <=20 to >=30)(one year)
- Laser Fluorescence Progression-12 Month (Increase at Least 10)(one year)