Photodisinfection -- which combines low-intensity laser energy and microbiological stains to target and destroy microbial pathogens -- continues to demonstrate its effectiveness in the treatment of chronic adult periodontitis. According to Ondine Biopharma, the Vancouver-based company commercializing this technology under the product name Periowave, results from the Canadian Multi-Center Gum Disease Trial demonstrate that photodisinfection compares favorably to traditional scaling and root planing for the treatment of periodontal disease.
The Canadian Multi-Center Trial was a prospective, randomized, examiner-blinded study that included 121 patients and 4,500 defect treatment sites. Fifty-eight patients were included in the Periowave treatment arm and 63 patients were included in the control arm. The study was conducted at the University of Western Ontario, the University of Alberta, the University of Saskatchewan, and at a large private periodontal clinic in Toronto. This trial was Ondine's fourth and largest study to date, comparing the Periowave to scaling and root planing for the treatment of periodontitis.
"The trial results confirm the positive in-field experiences of clinicians using the Periowave system in Canada and the European Union," said Carolyn Cross, president and CEO of Ondine. "Periowave represents a significant, nonantibiotic, minimally-invasive adjunctive approach to the treatment of gum disease. In addition to the latest clinical efficacy data, there have been no reported product-related adverse events."
The company intends to submit detailed results of this study to the FDA as part of its ongoing discussions with the FDA regarding marketing approval for Periowave in the United States. The product is currently approved in Canada and the European Union for several oral indications. Ondine submitted its 510(k) application for the Periowave to the FDA in September 2007.
The original photodisinfection technology behind the Periowave was developed by Professor Michael Wilson and colleagues at the Eastman Dental Institute, University College London, and licensed to Ondine by UCL Business, University College London.