Recruiting

PeriZone PerioPatch

Sponsor:

MIS Implant Technologies, Ltd

Code:

NCT01808703

Conditions

Chronic Periodontitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PeriZone PerioPatch

Scaling and root planing alone

Study Details

Brief summary:

The purpose of this study is to determine if a topical, adhesive patch (PeriZone PerioPatch) applied to the gums after a deep tooth cleaning (scaling and root planing) reduces the signs of advanced gum disease (chronic periodontitis) more than the deep tooth cleaning alone. Eighty patients with advanced gum disease will be recruited and treated within this clinical trial. Patients will be evaluated for changes in gum measurements over a 12-week period.

Conditions

Chronic Periodontitis

Study ID

NCT01808703

Start date

Mar, 2013

Status verified date

Mar, 2013

Completion date

Sep, 2013

Anticipated

Primary completion date

Sep, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult males or females 18 years or older
  • Able and willing to follow study procedures and instructions
  • Must have read, understood and signed an informed consent form
  • Present with at least 12 teeth in the functional dentition, excluding third molars
  • Generalized, moderate to severe chronic periodontitis
  • Present with at least two periodontal pockets (on separate teeth) measuring 6 mm or more and that bleed on probing

Exclusion Criteria:

  • Gross oral pathology
  • Chronic treatment (i.e., two weeks or more) with anti-inflammatory medications (steroids or nonsteroidal anti-inflammatory drugs) or any other medications known to affect periodontal status (e.g., phenytoin, calcium antagonists, cyclosporine and coumadin) within one month of the screening examination
  • Antibiotic treatment within 3 month prior to the screening examination
  • History of rheumatic fever, valvular disease, valve replacement or prosthetic joint replacement necessitating antibiotic prophylaxis
  • Active infectious diseases such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis
  • Reported allergies to herbal products
  • Taking herbal product supplements
  • Severe unrestored caries or any condition that is likely to require antibiotic treatment over the study
  • Periodontal therapy (quadrant or maintenance scaling and root planing and/or periodontal surgical therapy) within 6 months prior to enrollment.
  • Female patients who report being pregnant or lactating, or female patients who are of childbearing potential and who are not using hormonal, barrier methods of birth control (e.g., oral or parenteral contraceptives, diaphragm plus spermicide, condoms), or abstinence

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Scaling and root planing plus PerioPatch

All subjects in this group will receive scaling and root planing (full mouth during no more than 2 sessions within two weeks following the Baseline exam). Thereafter, PeriZone PerioPatch will be dispensed to subjects per randomization for administration over the trial period. Subjects will apply study patches (i.e., BID on Days 1, 28 and 42; QD on Days 2-6; Days 14-20, 29-30 and 43-44) to designated "treatment sites" (i.e., measuring 6 mm or more in pocket depth at Baseline).

active comparator: Scaling and root planing alone

Subjects in this group will receive only scaling and root planing (full mouth during no more than 2 sessions within two weeks following the Baseline exam).

Interventions

PeriZone PerioPatch

The PeriZone PerioPatch is an approved barrier or device product intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa (510K number K103054). PerioPatch devices will be applied adjunctively following scaling and root planing).

Scaling and root planing alone

Following completion of the Baseline examination, all randomized patients will receive full mouth scaling and root planing at a maximum of two visits within a 14-day time period (Weeks -2 to 0). Use of hand curettes and/or ultrasonic instruments will be permitted. Local or topical anesthesia may be used for patient comfort at the discretion of the clinician performing the scaling and root planing.

Primary outcome measure

  • Change in pocket depth (PD)from Baseline [ Time Frame: At 4, 8 and 12 weeks ]

Central Contacts and Locations

Central contacts

David W Paquette, DMD, DMSc

(631) 624-5937david.paquette@stonybrook.edu

Locations

School of Dentistry, University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599-7450

Contacts

Wendy Lamm, BS

919-537-3418wendy_lamm@dentistry.unc.edu

Principal Investigator:

Rebecca S Wilder, MS

G. W. Hirschfeld School of Dental Hygiene, Old Dominion University

Recruiting

Norfolk, Virginia, United States, 23529

Contacts

Gayle B McCombs, MS

757-683-5150gmccombs@odu.edu

Principal Investigator:

Gayle B McCombs, MS

More Information

Sponsor

MIS Implant Technologies, Ltd

Last update posted

Mar 11, 2013

Last verified

Mar, 2013

Keywords

  • Periodontitis
  • Periodontal pocket
  • Periodontal diseases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by MIS Implant Technologies, Ltd on 2013-03-11.