Clinical trial NCT03671512: Standard Root Planing vs. Periodontal Structure Repair Device for Treatment of Pockets Caused by Periodontal Disease
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Lead sponsor: Periovance, Inc
Sponsor class: INDUSTRY
First posted: 2018-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in periodontal pocket depth compared to standard root planing at 8 weeks
timeFrame: 8 weeks
measure: An acceptable safety profile at Visit Week 8 as evidenced by no clinically significant increase in the occurrence of select adverse events
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in periodontal pocket depth compared to standard root planing at 12 and 16 weeks
timeFrame: 12 weeks and 16 weeks
measure: Change in clinical attachment level compared to standard root planing at Visit Weeks 4, 8, 12 and 16
timeFrame: 4, 8, 12, 16 weeks
measure: To evaluate the percentage of subjects who achieve 15% and 25% improvements over baseline for pocket depth reduction for PSR-treated versus root-planed teeth.
timeFrame: 4, 8, 12, 16 weeks
measure: To evaluate the percentage of subjects who achieve 15% and 25% improvements over baseline for clinical attachment level for PSR-treated versus root-planed teeth
timeFrame: 4, 8, 12, 16 weeks
measure: Degree of inflammation following procedure
timeFrame: 8 weeks
measure: Degree of erythema following procedure
timeFrame: 8 weeks
measure: Presence or absence of bleeding on probing following procedure
timeFrame: 8 weeks
measure: Degree of Pain using the Pain Quality Assessment Scale (PQAS), National Initiative on Pain Control™ (NIPC).
timeFrame: 8 weeks
measure: Gingival Infection: Presence of gingival infection
timeFrame: 8 weeks
measure: Sensitivity
timeFrame: 8 weeks
measure: Tooth mobility of PSR-treated teeth versus standard root planing
timeFrame: 8 weeks
measure: Safety profile of the PSR procedure versus standard root planing for management of periodontal pocket disease through Visit Week 16.
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham School of Dentistry
state: Alabama
city: Cambridge
country: United States
facility: Forsyth Institute
state: Massachusetts
city: Stony Brook
country: United States
facility: Stony Brook School of Dental Medicine
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill School of Dentistry
state: North Carolina
Study officials:
affiliation: Periovance, Inc
name: Michael Fare
role: STUDY_CHAIR
References: