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

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ClinicalTrials.gov Identifier: NCT03671512
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Periovance, Inc

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.

Condition or disease Intervention/treatment Phase
Periodontal Diseases Device: Periodontal Structure Repair (PSR) Device: Standard Root Planing Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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.
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.
Primary Purpose: Treatment
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.
Actual Study Start Date : December 6, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Arm Intervention/treatment
Experimental: Periodontal Structure Repair (PSR)
Periodontal pockets treated with PSR
Device: Periodontal Structure Repair (PSR)
Following local anesthesia, initial pocket preparation will be done by bur abrasion utilizing specially designed burs to plane the root surface and remove the inner lining of the pocket. Following bur abrasion, thin strips of gauze sponge are placed into the created space. After removing the gauze strips, PSR is inserted to fill the spaces beginning at the pocket bottom. The final step is placing a layer of cyanoacrylate on both the gingival margin and tooth supragingivally.

Active Comparator: Standard Root Planing (SRP)
Periodontal pockets treated with SRP
Device: Standard Root Planing
Ultrasonics and hand instruments are used to remove any subgingival deposits on the roots. Standard instruments and standard application are used. Visual or instrument tactile inspection is used to verify the roots are hard-smooth and have been adequately cleaned.




Primary Outcome Measures :
  1. Change in periodontal pocket depth compared to standard root planing at 8 weeks [ Time Frame: 8 weeks ]
    The pocket depth is measured using a Williams' periodontal probe. The probe is inserted into the pocket until resistance is met. The depth of the pocket is measured in millimeters (mm) indicated on the probe. Measure the distance from the gingival margin to the tip of the periodontal probe. Each pocket will have six measurement taken around the tooth. The pocket depth measurements to be performed: buccal mesial, buccal, buccal distal, lingual mesial, lingual, lingual distal.


Secondary Outcome Measures :
  1. Change in periodontal pocket depth compared to standard root planing at 12 and 16 weeks [ Time Frame: 12 weeks and 16 weeks ]
    The pocket depth is measured using a Williams' periodontal probe. Each pocket will have six measurements taken around the tooth at the following locations: buccal mesial, buccal, buccal distal, lingual mesial, lingual, lingual distal.

  2. Change in clinical attachment level compared to standard root planing at 8 weeks [ Time Frame: 8 weeks ]
    The gingival margin level measurements to be performed: buccal mesial, buccal, buccal distal, lingual mesial, lingual, lingual distal.

  3. 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 at 8 weeks. root planing [ Time Frame: 8 weeks ]
    Each pocket will have six measurement taken around the tooth. The pocket depth measurements to be performed include: buccal mesial, buccal, buccal distal, lingual mesial, lingual, lingual distal

  4. 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 at 8 weeks [ Time Frame: 8 weeks ]
    The gingival margin level measurements to be performed: buccal mesial, buccal, buccal distal, lingual mesial, lingual, lingual distal.

  5. Degree of inflammation following procedure [ Time Frame: 8 weeks ]

    Inflammation measured the Gingival Index (Löe and Silness, 1963).

    • 0 = Normal gingiva
    • 1 = Mild inflammation: slight change in color, slight edema. No bleeding on probing.
    • 2 = Moderate inflammation: redness, edema, and glazing. Bleeding on probing.
    • 3 = Severe inflammation: marked redness and edema. Ulceration. Tendency for spontaneous bleeding.

  6. Degree of erythema following procedure [ Time Frame: 8 weeks ]

    Gingival erythema - measured using the Modified Gingival Index (MGI) (Lobene et al. 1986)

    • 0 = absence of inflammation;
    • 1 = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary;
    • 2 = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary;
    • 3 = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary;
    • 4 = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration.

  7. Presence or absence of bleeding on probing following procedure [ Time Frame: 8 weeks ]
    Bleeding on probing will be reported by a yes/no response

  8. Degree of infection following procedure [ Time Frame: 8 weeks ]
    Presence of gingival infection will be recorded by a yes/no response

  9. Degree of pain following procedure [ Time Frame: 8 weeks ]
    Measured by the Pain Quality Assessment Scale (PQAS). Nineteen pain qualities are assessed on scales of 0 to 10,with zero being not pain and 10 being the most pain imaginable.

  10. Degree of swelling following procedure [ Time Frame: 8 weeks ]

    Gingival swelling will be measured using the Sulcus Bleeding Index (SBI)

    • Score 0 - healthy looking gingiva no bleeding on probing:
    • Score 1 - healthy looking gingiva, bleeding on probing;
    • Score 2 - bleeding on probing, change in color, no edema;
    • Score 3 - bleeding on probing, change in color, slight edema;
    • Score 4 -bleeding on probing, change in color, obvious edema;
    • Score 5 -spontaneous bleeding, change in color, marked edema

  11. Tooth mobility of PSR-treated teeth versus standard root planing [ Time Frame: 8 weeks ]

    Tooth mobility will be assessed using the Tooth Mobility Scale (Miller, 1985)

    • Class 1: <1mm (horizontal) movement of the tooth
    • Class 2: >1mm (horizontal) movement of the tooth
    • Class 3: >1mm (horizontal and vertical mobility) of the tooth

  12. Safety profile of the PSR procedure versus standard root planing for management of periodontal pocket disease up to 16 weeks [ Time Frame: 16 weeks ]
    Related adverse events will be described and recorded for both treatment arms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671512


Contacts
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Contact: Robert Michel 215.650.7121 bmichel@periovanceinc.com

Locations
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United States, Alabama
University of Alabama at Birmingham School of Dentistry Recruiting
Birmingham, Alabama, United States, 35294
Contact: Nicolaas Geurs, DDS    205-934-1074    ngeurs@uab.edu   
United States, New York
Stony Brook School of Dental Medicine Recruiting
Stony Brook, New York, United States, 11794-8703
Contact: Srinivas Myneni, DDS    631-632-8739    SrinivasRao.MyneniVenkatasatya@stonybrook.edu   
United States, North Carolina
University of North Carolina at Chapel Hill School of Dentistry Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Christiano Susin, DDS    919-537-3727    csusin@email.unc.edu   
Sponsors and Collaborators
Periovance, Inc
Investigators
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Study Chair: Michael Fare Periovance, Inc

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Responsible Party: Periovance, Inc
ClinicalTrials.gov Identifier: NCT03671512     History of Changes
Other Study ID Numbers: PSR-001
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases