IFI16 is a Periodontitis Modulating Protein

A total of 72 subjects will be enrolled. Specifically, a sufficient number of adults 18 years
and older will be screened until 36 healthy (PPC-A) subjects and 36 subjects with severe
periodontal disease (PPC-G) will be enrolled. Eligibility for study participation will be
determined during the screening session. Barring dropout, subject participation will include
1 to 8 visits lasting over a maximum period of 42 days. The last 3 visits (visit 5-8) will
depend on the individual need of the subject for providing SRP. Clinical data and medical
history data will be collected at the screening visit to ascertain eligibility. All subjects
will have dental plaque and a gingival biopsy collected at baseline. Enrolled subjects will
be included in an experimental gingivitis model Stent-Induced Biofilm Overgrowth (SIBO) for
21 days. Individuals will return for safety checks every week during the 21-day period. At
21-days, plaque samples and a gingival biopsy will be collected. For diseased individuals SRP
will initiate during the 21-day visit at the SIBO quadrant. Visit 6 (28 days) will include
the post-biopsy follow up, prophylaxis (for healthy individuals) and SRP (diseased
individuals). Subjects receiving SRP may have 2 additional visits (visit 7 at day 35 and
visit 8 at day 42) for completing the SRP of all quadrants and will be dependent on
individual need. Medical histories, demographics, height and weight, clinical and biological
data described above will be recorded and stored on a secure server located at the University
of North Carolina. Each participant enrolled into the study will have a unique identification
number that has been stripped of any information that could be used by non-study members to
identify the subject.

Inclusion Criteria:

- Subjects must have read, understood and signed an informed consent form.

- Subjects must be able and willing to follow study procedures and instructions.

- Subjects must be adult males or females with a minimum of 18 years (inclusive).

- Subjects must present with at least 20 teeth in the functional dentition, excluding
third molars.

- Subjects must have at least 3 teeth in each posterior sextant

- Subjects must be in good general health

- Subjects must be in the healthy (PPC-A) or severe periodontitis (PPC-G) categories
according to the PPC (1)

Exclusion Criteria:

- If the sextants identified for the analysis has implants

- All individuals who meet criteria for anti-infective prophylaxis prior to dental
procedures

- Chronic disease with oral manifestations including diabetes mellitus.

- Current smoker or one that has stopped smoking less than 2 years prior to enrollment.

- Gross oral pathology other than the periodontal disease.

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

- Chronic treatment (i.e., two weeks or more) with any medication known to affect
periodontal status (e.g., phenytoin, calcium antagonists, cyclosporin, coumadin,
non-steroidal anti-inflammatory drugs, aspirin) within one month of the screening
examination.

- 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).

- Significant organ disease including impaired renal function, heart murmur, history of
rheumatic fever or valvular disease, or any bleeding disorder.

- Individuals with prosthetic material used for intra-cardiac repair (e.g. for
congenital heart disease), or intra-cardiac devices, cardiac transplant, infective
endocarditis and individuals who have had previous infectious complications of
prosthetic joint infections

- Infectious diseases such as hepatitis, HIV or tuberculosis.

- Anemia or other blood dyscrasias.

- Anticoagulant therapy or drugs, such as heparin or warfarin.

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

- Pregnant, or expect to become pregnant within the next several months.

- Females of child-bearing capacity must be willing to have pregnancy test to confirm
they are not pregnant.

- Females of child-bearing capacity not using any form of contraceptive methods

- Anything that would place the individual at increased risk or preclude the
individual's full compliance with or completion of the study.