Phase 3
N=394
Healozone Study to Evaluate the Safety and Efficacy of the Use of Ozone for Management of Dental Caries
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT00495495 ↗Enrolled (actual)
394
Serious AEs
1.3%
Results posted
Dec 2010
Primary outcome: Primary: ICDAS Severity Value — 17; 22; 278; 273 teeth — p=0.1126
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ozone treatment (Device); Placebo treatment (Device)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ICDAS Severity Value |
17; 22; 278; 273 | 0.1126 |
| SECONDARY Change in Caries Lesion Activity |
189; 164; 106; 131 | .9777 |
| SECONDARY Progression of Radiographic Scores at 12 Months |
6; 12; 220; 214 | .0416 sig |
| SECONDARY Laser Fluorescence Progression-12 Month (Increase From <=20 to >=30) |
16; 14; 277; 279 | 0.6585 |
| SECONDARY Laser Fluorescence Progression-12 Month (Increase at Least 10) |
58; 52; 235; 241 | .7666 |
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.
Eligibility Criteria
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; 2. be between the ages of 10 and 40 years of age; 3. 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.) 4. be in good general health as evidenced by a review of the medical history; 5. have good oral health; 6. 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 7. 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.
Data sourced from ClinicalTrials.gov (NCT00495495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.