Standard Root Planing vs. Periodontal Structure Repair Device for Treatment of Pockets Caused by Periodontal Disease

This is a multicenter, prospective, randomized, open, active comparator-controlled study with
a parallel group, subject-paired design (i.e. the effect of both treatments can be observed
in the same subject).

Subjects must have two quadrants of their mouth that each have at least two teeth with one or
more pockets per tooth that are 5-8 mm in depth. Subjects having more than 2 quadrants will
have the first 2 quadrants randomized to receive two different treatments (one quadrant root
planing and one quadrant PSR procedure) from the group of available quadrants.

Investigators will assess the efficacy of the Periodontal Structure Repair device (PSR) as
measured by a reduction in pocket depth.

Inclusion Criteria:

1. Subjects must be in stable health as determined by lack of clinically significant
abnormalities as assessed at screening.

2. Subjects must have a minimum of 2 teeth with a pocket depth of 5 to 8 mm per quadrant
in at least two quadrants of the mouth with bleeding on probing.

3. Signed and dated informed consent form, meeting all criteria of current FDA
regulations and approved by the assigned IRB.

4. Subject must be willing and able to follow all the post treatment oral hygiene
requirements.

5. Subjects must be in stable systemic health.

Exclusion Criteria:

1. History of allergy or sensitivity to any of the PSR paste ingredients or other
products used in the PSR or Root Planing procedure.

2. Subjects who demonstrate during the pre-treatment prophylaxis cleaning visit that they
cannot adequately comply with post treatment dental hygiene requirements of the study.

3. History or current evidence of chronic infectious disease, system disorders, organ
dysfunction, cardiovascular disorders, stroke, renal or hepatic disorder, diabetes or
bleeding disorders that may prevent the subject from tolerating the root planing or
PSR procedure. Any significant clinical illness within 90 days of the study start. If
any doubt is present regarding the accuracy of the subject's medical history or their
suitability to participate, appropriate consultation should be sought or the subject
excluded.

4. Wears braces or had any dental procedures within 2 weeks of entering the study. Any
significant dental issues noted during the screening oral examination. Any ongoing
clinically significant trauma or infectious diseases in the oral cavity.

5. Any previous periodontal procedures including root planing within 6 months of entering
the study.

6. Presence of a medical condition requiring regular treatment with antibiotics or
treatment with antibiotics within six months prior to entry into the study.

7. Presence of a medical condition requiring treatment with anticoagulant therapy or
drugs, such as heparin or warfarin.

8. History of psychiatric disorders occurring within the last two years that required
hospitalization or medication.

9. Receipt of an Investigational drug as part of a research study within 30 days or 10
half-lives (whichever is longer) prior to entry into the trial.

10. A clinically significant abnormality is detected in the subject's screening blood or
urine samples (clinical chemistry, hematology, or urinalysis) that in the opinion of
the investigator should prohibit inclusion into the trial.

11. Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody at
screening.

12. Subject is not able to communicate well with the Investigator, to understand and
comply with the requirements of the study, or to understand the written informed
consent

13. Subject is not suitable to participate in the study in the opinion of the Investigator

14. Teeth with any furcation defects or mobility >2 will be excluded from treatment in
both arms of the study.

15. Medication that alters or affects healing such as chemotherapy, immune-suppressive
medications within two months of study start.

16. Subjects having received doses of corticosteroids in excess of 20mg per day within 2
months of study start.

17. Subjects who are pregnant or planning to become pregnant during the course/duration of
the clinical trial period.