Status:
UNKNOWN
Clinical Trial of PeriZone PerioPatch in Subjects With Chronic Periodontitis
Lead Sponsor:
MIS Implant Technologies, Ltd
Conditions:
Chronic Periodontitis
Eligibility:
All Genders
18+ years
Phase:
NA
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 gu...
Detailed Description
Objectives: 1) to evaluate the efficacy of PeriZone PerioPatch (FDA approved device, 510K number K103054) in reducing pocket depth (PD) in subjects with moderate to severe chronic periodontitis; and 2...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01808703
Start Date
March 1 2013
End Date
September 1 2013
Last Update
March 11 2013
Active Locations (2)
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1
School of Dentistry, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7450
2
G. W. Hirschfeld School of Dental Hygiene, Old Dominion University
Norfolk, Virginia, United States, 23529