Clinical Trial of PeriZone PerioPatch in Subjects With Chronic Periodontitis

Objectives: 1) to evaluate the efficacy of PeriZone PerioPatch (FDA approved device, 510K
number K103054) in reducing pocket depth (PD) in subjects with moderate to severe chronic
periodontitis; and 2) to assess the effect of PeriZone PerioPatch on secondary clinical
outcomes associated with chronic periodontitis including bleeding on probing (BOP), clinical
attachment level (CAL), Gingival Index (GI) and Plaque Index (PI).

Participants: A total of 80 participants with generalized moderate to severe chronic
periodontitis will be recruited for this clinical trial.

Trial Design: This study is a multicenter, randomized, single blind, and controlled design
trial with two parallel arms. The 2 arms of the study are:

- Arm A - Scaling and root planing plus PeriZone PerioPatch;

- Arm B - Scaling and root planing alone (control group).

Procedures (methods): After potential patients have been screened, informed consent forms
are signed, and patients have completed the remaining screening evaluations, each patient
will be randomized to a treatment group. Patients must present with generalized, moderate to
severe chronic periodontitis defined as having at least two periodontal pockets measuring 6
mm or more and bleeding on probing (at Baseline).

Periodontal probing measurements (PD, CAL, GI and PI) will be performed at Baseline (prior
to randomization), and at Weeks 4, 8 and 12. All subjects will receive scaling and root
planing (full mouth during at most 2 sessions within two weeks following the Baseline exam).
Thereafter, PeriZone PerioPatch will be dispensed to subjects per randomization for
administration over the trial period (i.e., Days 1-6; Days 14-20; Days 28-30; Days 42-44).
Intraoral soft tissue inspection will be performed at Screening, Baseline and at Weeks 4, 8
and 12. Adverse event collection will be performed at Weeks 4, 8 and 12. Compliance will be
will be evaluated via collection of unused study devices.

Analysis Plan: Baseline and demographic data will be summarized by treatment. Adverse events
and safety outcomes will be categorized by treatment and summarized with descriptive
statistics. Changes in probing depths, bleeding scores, clinical attachment levels Gingival
Index and Plaque Index scores (from Baseline) will be expressed as means per subjects and
tested for inter-group differences using nonparametric rank analysis of covariance.

Inclusion Criteria:

- Adult males or females 18 years or older

- Able and willing to follow study procedures and instructions

- Must have read, understood and signed an informed consent form

- Present with at least 12 teeth in the functional dentition, excluding third molars

- Generalized, moderate to severe chronic periodontitis

- Present with at least two periodontal pockets (on separate teeth) measuring 6 mm or
more and that bleed on probing

Exclusion Criteria:

- Gross oral pathology

- Chronic treatment (i.e., two weeks or more) with anti-inflammatory medications
(steroids or nonsteroidal anti-inflammatory drugs) or any other medications known to
affect periodontal status (e.g., phenytoin, calcium antagonists, cyclosporine and
coumadin) within one month of the screening examination

- Antibiotic treatment within 3 month prior to the screening examination

- History of rheumatic fever, valvular disease, valve replacement or prosthetic joint
replacement necessitating antibiotic prophylaxis

- Active infectious diseases such as hepatitis, human immunodeficiency virus (HIV) or
tuberculosis

- Reported allergies to herbal products

- Taking herbal product supplements

- Severe unrestored caries or any condition that is likely to require antibiotic
treatment over the study

- Periodontal therapy (quadrant or maintenance scaling and root planing and/or
periodontal surgical therapy) within 6 months prior to enrollment.

- Female patients who report being pregnant or lactating, or female patients who are of
childbearing potential and who are not using hormonal, barrier methods of birth
control (e.g., oral or parenteral contraceptives, diaphragm plus spermicide,
condoms), or abstinence