Healozone Study to Evaluate the Safety and Efficacy of the Use of Ozone for Management of Dental Caries

NCT00495495 | Completed Phase 2 Results DMC

• 3 other identifiers: 07-D-187IDE G50008Clinical Trials. gov
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 3

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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• ICDAS Severity Value

  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.

  Baseline and One Year

Secondary Outcomes (4)

• 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

Study Arms (2)

Ozone treatment

EXPERIMENTAL

Ozone treatment of randomly selected study tooth for 60 seconds

Device: Ozone treatment

Placebo, no ozone

PLACEBO COMPARATOR

Placebo treatment (no ozone) of randomly selected study tooth for 60 seconds.

Device: Placebo treatment

Interventions

Ozone treatment DEVICE

Ozone treatment applied to randomly selected tooth for a period of 60 seconds at Baseline, Three, Six and Nine-Month visits.

Also known as: HealOzone unit

Ozone treatment

Placebo treatment DEVICE

Placebo treatment applied to randomly selected tooth for a period of 60 seconds at Baseline, Three-, Six- and Nine-Month visits.

Placebo, no ozone

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• Tufts University School of Dental Medicine: collaborator
• State University of New York at Buffalo: collaborator

Study Sites (3)

Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

State University of New York at Buffalo, School of Dental Medicine

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Limitations and Caveats

Study length may have been too brief to permit progression of early stage caries; Low caries increment in study population; Difficult to establish that lesions were truly active at baseline.

Results Point of Contact

• Title: Domenick T. Zero, DDS MS Principal Investigator
• Organization: Indiana University School of Dentistry

dzero@iupui.edu

317-274-8822

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2007
• First Posted: July 3, 2007
• Study Start: February 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 20, 2015
• Results First Posted: December 23, 2010

Record last verified: 2015-02

Locations

US (3)