Standard Root Planing vs. Periodontal Structure Repair Device for Treatment of Pockets Caused by Periodontal Disease
Purpose
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.
Condition
- Periodontal Diseases
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- For each subject, one quadrant will be randomized to PSR and the other quadrant will be randomized to conventional scaling and root planing.
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- The assessments of efficacy measurements of pocket depth and attachment gain CAL will be performed by a dental professional staff member at the investigator site who is blinded to which procedure was performed in each quadrant. Whenever possible, the same staff member will make these assessments throughout the study. The pocket depth assessments will be performed by a dental professional who has been trained on the actual method. Personnel will be trained to use the University of North Carolina (UNC) probe by the central trainer provided by the sponsor or CRO.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Periodontal Structure Repair (PSR) |
Periodontal pockets treated with PSR |
|
|
Active Comparator Standard Root Planing (SRP) |
Periodontal pockets treated with SRP |
|
More Details
- Status
- Completed
- Sponsor
- Periovance, Inc
Study Contact
Detailed Description
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.