Salivary Inflammatory Biomarkers: Predictors & Comparative Effects of Sonicare/Elite-Flexcare in Stages of Perio Disease

Randomized controlled trial to determine clinical and inflammatory benefits of Sonicare
Flexcare tooth brushing following experimental induction of biofilm overgrowth in various
periodontal conditions.

This research study has both a Diagnostic Aim and a Treatment Aim. Aim #1 is to examine the
utility of candidate inflammatory biomarkers within saliva to discriminate between health,
gingivitis, mild, moderate and severe periodontis; and to discriminate between active versus
inactive states of periodontal disease to see if these basal levels can predict the clinical
response to biofilm overgrowth among various periodontal conditions; Aim #2 is to extend the
claim of the anti-inflammatory and anti-infective efficacy of the Sonicare/Elite-Flexcare as
compared to manual brushing to include 4 levels of periodontal disease [BGI-G, P1, P2 and
P3].

The devices used in this study are subject only to Class I (general controls) and considered
exempt from the premarket notification procedures and not subject to section 510(k), 515, or
520(m,) of the FDC Act in order to be legally marketed. Thus, the study does not meet the
definition of an Applicable Clinical Trial.

Inclusion Criteria:

1. adult males or females between the ages of 18 and 75 years (inclusive).

2. able and willing to follow study procedures and instructions.

3. read, understood and signed an informed consent form.

4. present with at least 8 teeth in the functional dentition with a minimum of 3 adjacent
teeth with interproximal papilla in each posterior sextant that will have the stent.

5. be in good general health.

6. present with one of the following five categories to be considered for enrollment

- BGI health (all PD<3mm, BOP<10%)

- BGI-gingivitis (all PD≤3mm, BOP≥10%)

- BGI-P1 (1+ site with PD>3mm, BOP≤10%)

- BGI-P2 (1+ site with PD>3mm, BOP>10% but BOP≤50%)

- BGI-P3 (1+ site with PD>3mm, BOP>50%)

Exclusion Criteria:

1. chronic disease with oral manifestations or active infectious diseases such as
hepatitis, HIV or tuberculosis.

2. gross oral pathology.

3. treatment with antibiotics for any medical or dental condition within 1 month prior to
the screening examination.

4. chronic treatment (i.e., two weeks or more) with any medication known to affect
periodontal status (e.g., phenytoin, calcium antagonists, cyclosporin, anticoagulants,
non-steroidal anti-inflammatory drugs, high dose aspirin such as >100mg per day)
within one month of the screening examination.

5. ongoing medications initiated less than three months prior to enrollment (i.e.,
medications for chronic medical conditions must be initiated at least three months
prior to enrollment).

6. clinically significant organ disease including impaired renal function, and/or any
bleeding disorder.

7. severe unrestored caries, or any condition that is likely to require antibiotic
treatment during the study, including the need for prophylactic antibiotic.

8. use any tobacco products or who have used tobacco products within the previous six
months of the screening examination.

9. pregnant, or expect to become pregnant within the next three months and individuals
nursing.

10. dental appliances that will interfere with stent construction.