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Pharmacoeconomic Study of the Use of PerioChip in the Treatment of Adult Periodontitis

PI: Roy C. Page, D.D.S., Ph.D., Professor of Periodontics, Director RCDRC, Associate Dean, School of Dentistry, and Professor of Pathology, School of Medicine, University of Washington

PerioChip is a small, biodegradable film of hydrolyzed gelatin containing 2.5 mg of chlorhexidine gluconate. Chlorhexidine is an antimicrobial agent which has been approved for use in the U.S. as a topical oral rinse. It has been widely used in dentistry to control bacterial growth on the surfaces of teeth. PerioChip has been designed to be inserted into periodontal pockets with depths greater than 5 mm where it releases the active drug and undergoes biodegradation over a period of 5 to 10 days. The primary objective of this study is to compare the dental health resource utilization and the associated costs by patients receiving standard periodontal therapy plus PerioChip versus patients receiving standard periodontal therapy alone. The primary outcome measure was the total value of billed charges for periodontal care during the twelve month trial period. The secondary study objectives were: 1) to study the effect of PerioChip on periodontal treatment needs (including periodontal surgical treatments, tooth extractions and all others) during a one year course of therapy; 2) to study the time necessary for placement of the PerioChip. Patients with adult periodontitis were randomized into groups one and two. All patients in both groups were provided standard periodontal therapy consisting initially of scaling and root planing. For patients in group two, a PerioChip was inserted into all pockets that were 5 mm or greater in depth following scaling and root planing. Additional therapy was provided at three, six, nine and 12 months consisting of that judged by the treating dentist to be indicated. The study was conducted at ten geographic locations of which RCDRC was one. At each location, a group of five periodontally aware dentists was recruited for participation in the study. Each dentist recruited and enrolled between 8 and 12 patients. The goal was to have a minimum of 500 patients who completed the study and who were evaluable. 66 patients were enrolled at RCDRC. Drop outs were negligible. The study has been completed. In the l2 month study period, periodontal surgery was recorded for l5.5% of SRP patients and 9.2% of SRP+CHIP patients (p = 0.042). Total dental charges (excluding CHIP costs) over l year averaged $l,4l6 for SRP and $l,229 for SRP + CHIP (p = 0.038) Totals with CHIP were $l,4l6 for SRP and $l,6l6 for SRP + CHIP (p = 0.03l). These data indicate that CHIP significantly reduced the number of periodontal surgeries performed over l year and reduced non-CHIP costs, but due to the low number of surgeries performed, this reduction was not sufficient to offset the total costs of CHIP use. The data suggest that the number of surgical procedures recommended by periodontal specialists is greatly increased compared to general practitioners. PerioChip has been FDA approved and is now on the market in the U.S.

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