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

A Phase III, Prospective, Randomized, Active Comparator-controlled, Parallel Group, Subject-paired Study Comparing Standard Root Planing vs. a Periodontal Structure Repair Device for Treatment of Pockets Caused by Periodontal Disease.

This study evaluates the efficacy and safety of Periodontal Structure Repair device (PSR) compared to conventional periodontal therapy (scaling and root planing) for the treatment of periodontal 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 scaling and root planing or PSR device and procedure or 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, e.g., the Chief Medical Officer of InClinca (the CRO) 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 scaling and 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. Subjects prescribed ≤ 325 mg/day of aspirin should not be excluded and this treatment should not be stopped during their participation in this trial.
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.