As periodontitis affects nearly half of the adults in the United States, according to the Centers for Disease Control and Prevention, researchers at the University of Pennsylvania School of Dentistry are exploring the use of an experimental gel formulation developed by Geistlich Pharma called PerioSept in treatment.
Taurolidine is the active ingredient in PerioSept and the target of the investigation. Derived from the amino acid taurine, it has been shown to have antimicrobial and immune-modulating properties, safely used in various formulations for clinical indications such as peritonitis and sepsis. Also, it has been included in marketed drug products outside the United States since 1981, and formulations that include it have been approved in 5 countries.
The Phase II clinical trial will investigate the safety, tolerability, and effectiveness of PerioSept (with up to 3% taurolidine) as an adjunctive treatment in conjunction with scaling and root planing in subjects with moderate to severe periodontitis. The school is one of 5 sites in the United States conducting the trials, which will run for 6 months.
Subjects will be studied in 5 groups: the scaling and root planing-only group, the placebo group, and 3 groups receiving 0.3%, 1%, and 3% levels of the taurolidine, respectively. PerioSept is deposited into the pockets around diseased teeth. All of the 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,” said Joseph Fiorellini, DMD, DMSc, professor with the school’s department of periodontics and principal investigator of the study.