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

NCT03671512 | Completed DMC FDA Device

• 1 other identifier: PSR-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (2)

• Change in periodontal pocket depth compared to standard root planing at 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.

  8 weeks

• An acceptable safety profile at Visit Week 8 as evidenced by no clinically significant increase in the occurrence of select adverse events

  The primary safety endpoints are to demonstrate an acceptable safety profile at Visit Week 8 as evidenced by no clinically significant increase in the occurrence of any of the following adverse events for the PSR-treated pockets versus the current standard of treatment for periodontal pockets (scaling and root planing): 1. an increase in pocket depth ≥ 2 mm 2. clinical signs and symptoms of an abscess 3. pain localized to the treated teeth.

  8 weeks

Secondary Outcomes (12)

• Change in periodontal pocket depth compared to standard root planing at 12 and 16 weeks

  12 weeks and 16 weeks

• Change in clinical attachment level compared to standard root planing at Visit Weeks 4, 8, 12 and 16

  4, 8, 12, 16 weeks

• 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.

  4, 8, 12, 16 weeks

• 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

  4, 8, 12, 16 weeks

• Degree of inflammation following procedure

  8 weeks

Study Arms (2)

Periodontal Structure Repair (PSR)

EXPERIMENTAL

Periodontal pockets treated with PSR

Device: Periodontal Structure Repair (PSR)

Standard Root Planing (SRP)

ACTIVE COMPARATOR

Periodontal pockets treated with SRP

Device: Standard Root Planing

Interventions

Periodontal Structure Repair (PSR) DEVICE

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.

Periodontal Structure Repair (PSR)

Standard Root Planing DEVICE

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.

Standard Root Planing (SRP)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be in stable health as determined by lack of clinically significant abnormalities as assessed at screening.
• 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.
• Signed and dated informed consent form, meeting all criteria of current FDA regulations and approved by the assigned IRB.
• Subject must be willing and able to follow all the post treatment oral hygiene requirements.
• Subjects must be in stable systemic health.

You may not qualify if:

• History of allergy or sensitivity to any of the PSR paste ingredients or other products used in the PSR or Root Planing procedure.
• Subjects who demonstrate during the pre-treatment prophylaxis cleaning visit that they cannot adequately comply with post treatment dental hygiene requirements of the study.
• 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.
• 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.
• Any previous periodontal procedures including scaling and root planing within 6 months of entering the study.
• Presence of a medical condition requiring regular treatment with antibiotics or treatment with antibiotics within six months prior to entry into the study.
• 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.
• History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
• 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.
• Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody at screening.
• 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
• Subject is not suitable to participate in the study in the opinion of the Investigator
• Teeth with any furcation defects or mobility \>2 will be excluded from treatment in both arms of the study.
• Medication that alters or affects healing such as chemotherapy, immune-suppressive medications within two months of study start.
• Subjects having received doses of corticosteroids in excess of 20mg per day within 2 months of study start.

Sponsors & Collaborators

• Periovance, Inc: lead

Study Sites (4)

University of Alabama at Birmingham School of Dentistry

Birmingham, Alabama, 35294, United States

Location

Forsyth Institute

Cambridge, Massachusetts, 02142, United States

Location

Stony Brook School of Dental Medicine

Stony Brook, New York, 11794-8703, United States

Location

University of North Carolina at Chapel Hill School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Michael Fare

  Periovance, Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: For each subject, one quadrant will be randomized to PSR and the other quadrant will be randomized to conventional scaling and root planing.

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 14, 2018
• Study Start: December 6, 2018
• Primary Completion: January 17, 2020
• Study Completion: March 9, 2020
• Last Updated: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)