Clinical Trial Studying New Drug for the Treatment of Periodontitis

Philadelphia — Adding to the clinical research being conducted within Penn Dental Medicine’s Department of Periodontics is a new clinical trial, recently launched to study PerioSept®, a new experimental gel formulation developed by Geistlich Pharma as an adjunctive therapy in the treatment of periodontitis. Dr. Joseph Fiorellini, Professor, Department of Periodontics, is principal investigator of the study.

The active ingredient under investigation is Taurolidine. Derived from the amino acid taurine, it has been shown to have antimicrobial and immune modulating properties, safely used in various formulations for a number of clinical indications, including peritonitis and severe sepsis. Taurolidine has been included in marketed drug products outside the U.S. since 1981, and taurolidine-containing formulations have approvals in five countries.

The main objective of this Phase II clinical trial is to investigate the safety, tolerability, and effectiveness of PerioSept® gel (containing up to 3 % taurolidine) as an adjunctive treatment in conjunction with scaling and root planing in subjects with moderate to severe periodontitis. Penn Dental Medicine is one of five sites in the U.S. conducting trials, which will run for six months. Subjects are being studied in five groups — the scaling and root planing only group, the placebo group, and three groups receiving different levels of the taurolidine (.3%, 1%, and 3%). PerioSept® is deposited into the pockets around diseased teeth. All groups in the study are receiving scaling and root planing.

“Along with compromising oral health, the association of periodontitis with systemic conditions — from atherosclerosis to diabetes — underscores the importance of implementing new and effective treatment options,” says Dr. Fiorellini.

Penn Dental Medicine is presently continuing to enroll patients in the study, who will receive periodontitis treatment and careful monitoring of their oral health throughout their participation in the study. For more information on enrolling, contact Dr. Yu Cheng Chang, yuchengc@upenn.edu.