Doxycycline Release from a Biodegradable Controlled-release Drug Delivery System (Atridox) Covered or not Covered with a Periodontal Adhesive

Objectives: This study was designed to compare levels of doxycycline hyclate (DH) in gingival crevicular fluid (GCF) following treatment with a controlled release drug delivery system containing DH (CRDH) retained with 2-octyl cyanoacrylate (AD) with levels of DH in subjects whose treated sites were not covered AD. Methods: CRDH was placed in pockets >4mm on the left side of the dentition of 50 subjects. Twenty-five of the subjects had their treated sites covered with AD. Twenty-five subjects received no AD. Prior to the placement of the CRDH and then 2,4,6,&8 hours and 1,3,5, and 7days after the placement GCF samples were taken from the treated sites. Two weeks later the subjects had a reapplication of the CRDH on the right side of their dentition.Those subjects who did not originally have their sites dressed received AD and vica versa. The GCF was assayed for DH utilizing reverse phase high performance liquid chromatography. Results: The percentage of sites that visually/tactily retained CRDH at day 3,5,&7 was 94,90,&89% when sites were dressed and 78, 64, &52% when no dressing was utilized. DH concentrations peaked at 2hrs; 1248ug/ml for the no dressing group, and 671ug/ml for the dressing group. These levels remained in excess of 115 ug/m through day 5. At day 7 the level of DH in the GCF was 32ug/ml for the no AD group and 93ug/ml for the AD group. Conclusions: There were no clinically significant differences in the ability to retain CRDH in the periodontal pocket in either of the two groups. There was extreme variability in the concentrations of DH in the GCF for both groups for all time points. However the concentration of DH in the GCF remained at levels considered to be therapeutic through day 7. Supported by Atrix Labs Inc Ft Collins, CO, USA