Results of a study published in the November issue of the Journal of Periodontology show that patients with periodontitis respond more favorably to a combined treatment of scaling and root planing (SRP) together with Arestin�, than to SRP alone. Arestin�, a locally delivered antibiotic (Minocycline Microspheres), is administered to patients with periodontitis as adjunct to SRP procedures. Arestin� is the lead product of OraPharma, Inc. (Nasdaq: OPHM), a specialty pharmaceutical company with an initial focus on the emerging field of oral health care.
The study, entitled �Treatment of Periodontitis by Local Administration of Minocycline Microspheres: A Controlled Trial� was conducted at 18 major US dental institutions for a period of nine months. The article was authored by a team led by Ray C. Williams, D.M.D., Professor and Chairman, Department of Periodontology, University of North Carolina, Chapel Hill, NC.
The study examined 748 patients, aged 30 or older with moderate to advanced periodontitis. Patients were randomized to one of three treatment arms: 1) SRP alone; 2) SRP plus vehicle (placebo); or 3) SRP plus Arestin�. The primary outcome measure was periodontal pocket depth reduction after 9 months. Clinical assessments of pocket depth were performed at the beginning of the study and after 1, 3, 6 and 9 months. Patients receiving SRP with Arestin� showed a 25% improvement in probing depth reduction after 9 months compared to patients receiving SRP alone, a 32% improvement compared to patients receiving SRP plus vehicle. The difference in periodontal pocket depth reduction was statistically significant after the first month and was maintained throughout the study.
�The findings of this study are significant,� said Michael D. Kishbauch, President and Chief Executive Officer. �The studies clearly indicate the advantages of using a combined treatment of Arestin� plus SRP is a more effective way to eliminate the bacteria that cause periodontal disease. With this development, we are enhancing the value of SRP and are providing a new weapon for the treatment of periodontal disease.�
Arestin� used in conjunction with SRP was also found to be more effective than SRP alone in more difficult to treat patients, such as those who smoke and those with more advanced periodontal disease. In smokers, SRP plus Arestin� was 32% more effective than SRP alone in reducing periodontal pockets, and in patients with the most advanced disease, adjunctive use of Arestin� was over 100% more effective.
�Our hypothesis going into this study was that using Arestin� with SRP would potentially better disinfect periodontal pockets, thereby giving us a superior clinical response,� Dr. Williams said. �We are extremely pleased with the results, which indicate that using a medical approach with Arestin� can significantly increase the response to mechanical debridement. This response is even better with patients that have deeper pockets, and in patients who traditionally have not responded well to periodontal therapy such as smokers. Lastly, we found Arestin� to be a fast and easy treatment, making it comfortable for patients and simple for professionals to incorporate into existing SRP procedures without increasing chair time.�
The Arestin� treatment group had no greater incidence of side effects when compared with groups receiving vehicle and SRP alone.
Periodontal disease destroys supporting gum tissue and bone, forming pockets around the teeth in which plaque and bacteria accumulate. The severity of periodontal disease is measured in part by the depth of these pockets. Periodontal disease is vastly under treated and may carry serious health risks. It affects more than 50 million people in the United States. Certain studies suggest a possible systemic link between periodontal disease and overall health including conditions such as coronary heart disease, stroke, diabetes, and pre-term, low infant birth weight.