Clinical Trial of PeriZone PerioPatch in Subjects With Chronic Periodontitis

Status unconfirmed · Not applicable

Conditions studied: Chronic Periodontitis

In brief

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.

Key facts

Study ID

NCT01808703

Run by

MIS Implant Technologies, Ltd

People needed

80

Starts

2013-03-01

Expected to finish

2013-09-01

Last updated by the study team

2013-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• School of Dentistry, University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• G. W. Hirschfeld School of Dental Hygiene, Old Dominion University — Norfolk, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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