CollaGenex Pharmaceuticals Inc announced the clinically and statistically significant results of a six-month, 180-patient clinical trial designed to evaluate the safety and efficacy of Periostat when combined with Atridox and scaling and root planning (SRP), versus SRP alone.
All patients entering the trial had eight diseased tooth sites with periodontal pocket depths of at least 5 mm. At the end of the six month study, patients in the Periostat + Atridox + SRP group showed a 48 per cent mean improvement in clinical attachment level and a 44 per cent mean reduction in periodontal pocket depths for pockets of 7 mm or greater at baseline, compared to comparable pockets in the patients who had SRP alone. Those deep pockets with baseline depths of 7 mm or greater and treated with combination therapy experienced an average reduction in pocket depth of more than 2 mm.
The results, showing that the patients receiving the combination of treatments experienced more than a 2 mm improvement in mean attachment gain and pocket depth reduction, were highly statistically significant when compared to SRP alone (p = less than 0.0001 for both parameters).
"These data clearly show the clinical benefit of combination host modulation and topical anti-microbial therapy when administered along with traditional scaling and root planning," said Dr. John Novak, director of Clinical Research at the University of Kentucky School of Dental Medicine and lead investigator. "An average reduction of 2 mm or more in deep periodontal pockets can mean the difference between being able to maintain the teeth with conservative, non-surgical therapy versus the use of more aggressive, surgical techniques. After six months of this type of comprehensive, non-surgical approach, more than three times as many patients had no further need for corrective periodontal surgery compared to those patients receiving scaling and root planning alone," he added.
"Periostat has demonstrated an outstanding record of safety and efficacy, with over 3 million prescriptions filled to date," said Colin Stewart, president and chief executive officer of CollaGenex. "The results from this combination trial add to the growing body of evidence supporting the use of Periostat and Atridox to treat this common and potentially debilitating disorder," he said.
Research has shown that certain unique properties of the tetracyclines discovered during the development of Periostat may be applicable to other diseases involving inflammation and/or destruction of the body's connective tissues, including acne, rosacea, meibomianitis and cancer metastases, among others. CollaGenex is further evaluating Periostat, as well as the new IMPACS compounds, to assess whether they are safe and effective in these applications. In addition, CollaGenex has licensed the Restoraderm technology, a unique, proprietary dermal drug delivery system, in order to develop a range of topical dermatological products with enhanced pharmacologic and cosmetic properties.