An in vivo Study of the chlorhexidine release profile of the PerioChip^TM in the gingival crevicular fluid, plasma and urine

Abstract

The release profile of chlorhexidine from the PerioChip (Chip), a biodegradable local delivery system that contains 2.5 mg of chlorhexidine gluconate (CHX) in a cross-linked hydrolyzed gelatin matrix, into the gingival crevice, was evaluated in an in vivo, open label, single-center, 10-day pharmacokinetic study conducted on 19 volunteers with chronic adult periodontitis. Each volunteer had a single chip inserted into each of 4 selected pockets, with probing pocket depths of between 5-8 mm, at time 0. Gingival crevicular fluid (GCF) samples were collected using filter paper strips prior to Chip placement and at 2 h, 4 h, 24 h and 2, 3, 4, 5, 6, 8, and 9 days post-Chip placement. The GCF volume was measured using a calibrated Periotron 6000. Blood samples were collected at times 0, 1, 4, 8, 12 h and 5 days post-dosing. Urine was collected as a total 24-h specimen immediately post-dosing and 2 single samples at time 0, prior to dosing, and 5 days. The CHX was eluted from the paper strips and the CHX levels in GCF, blood and urine quantified using HPLC. The results indicate an initial peak concentration of CHX in the GCF at 2 h post-Chip insertion (2007 microg/ml) with slightly lower concentrations of between 1300-1900 microg/ml being maintained over the next 96 h. The CHX concentration then progressively decreased until study conclusion with significant CHX concentrations (mean=57 microg/ml) still being detectable at study termination. CHX was not detectable in any of the plasma or urine samples at any time point during the study. These results indicate that the PerioChip can maintain clinically effective levels of CHX in the GCF of periodontal pockets for over 1 week with no detectable systemic absorption.

Clinical and antimicrobial efficacy of a controlled-release device containing chlorhexidine in the treatment of chronic periodontitis

“…Our results are similar to those reported in earlier multicentre clinical trials by Killoy [14], Soskolne et al [15], Jeffcoat et al [16] and Paolantonio et al [17], where CHX applied as a local drug delivery significantly reduced plaque index scores, bleeding on probing, probing pocket depth and gain in CAL< although no differences in gingival inflammation scores between the test and control sites were found at baseline. GI scores were reduced significantly in the test and control sites from baseline till the end of 3 months, which was in accordance with the findings observed by Soskolne et al [15], Jeffcoat et al [16] and Heasman et al [18].…”

“…GI scores were reduced significantly in the test and control sites from baseline till the end of 3 months, which was in accordance with the findings observed by Soskolne et al [15], Jeffcoat et al [16] and Heasman et al [18]. This reduction may be attributed to SRP, patient education and motivation.…”

Adjunctive Effects of A Piscean Collagen-Based Controlled-Release Chlorhexidine Chip in the Treatment of Chronic Periodontitis: A Clinical and Microbiological Study

“…Its safety and efficacy in reducing probing depth and bleeding on probing has been tested in clinical trials [19][20][21][22]. An in vitro release profile of chlorhexidine of 1105µg at 24 hours to 40µg by 7 days has been noted which is however not similar to the release profile of Periochip [19,38]. Periochip is a controlled local delivery system containing 2.5 mg of chlorhexidine gluconate incorporated into a biodegradable chip of hydrolyzed bovine gelatine has proven to inhibit more than 99% of subgingival microorganisms from periodontal pockets.…”

“…This concentration exceeds the minimum inhibitory concentration for more than 99% of subgingival microorganisms. In Periochip [38] an initial peak concentration of CHX in the GCF at 2 h post-Chip insertion (2007 µg/ml) was seen with slightly lower concentrations between 1300-1900 µg/ml being maintained over the next 96 h. The CHX concentration then progressively decreased until 9 th day with significant CHX concentrations (mean=57 µg/ml) still being detectable at 9 th day [38]. However, the results of this are in contradiction to those of Medaiah S et al, [39] study that showed no improvement with the adjunctive use of CHX chip.No adverse clinical events occurred in any of the study patients after placement of the collagen-based chlorhexidine chip.…”

Intermittierender Katheterismus der Harnblase — Hygienische Anforderungen und Befunde zur Zytotoxizität ausgewählter Katheter und Kathetergleitmittel in vitro

“…Untersuchungen an verschiedenen Schleimhäuten zeigten, dass keine relevante systemische Resorption von Chlorhexidin stattfindet (bei bukkaler, vaginaler Anwendung) [8,9,10]. Entsprechende Untersuchungen beim intermittierenden Katheterismus gibt es nicht.…”