SUSTAINED LOCAL-DELIVERY OF CHLORHEXIDINE IN THE TREATMENT OF PERIODONTITIS - A MULTICENTER STUDY

The safety and efficacy of a degradable, subgingivally placed drug del ivery system containing 2.5 mg chlorhexidine (CMC) were evaluated in a randomized, blinded, multi-center study of 118 patients with moderate periodontitis. A split-mouth design was used to compare the treatment outcomes of scaling and root planing (SRP) alone with the combined us e of SRP and the CHX in pockets with probing depths of 5 to 8 mm. The two maxillary quadrants were used for the two treatment arms of the st udy. Scaling and root planing was performed at baseline only, while th e CHX was inserted both at baseline and at 3 months. Clinical and safe ty measurements including probing depth (PD), clinical attachment leve l (GAL), and bleeding on probing (BOP) as well as gingivitis, plaque, and staining indices were recorded at baseline, and at 1, 3, and 6 mon ths. The average PD reduction in the CHX-treated sites was significant ly greater than in the sites receiving SRP alone at both 3 and 6 month s with a mean difference of 0.42 mm (P less than or equal to 0.01) at 6 months. The reduction in CAL at the treated sites was greater than a t the SRP sites, although the difference was statistically significant at the 6-month visit only. An analysis of patients with initial probi ng depths of 7 to 8 mm (n = 56) revealed a significantly greater reduc tion in PD and CAL in those pockets treated with CHX compared to SRP a t both 3 and 6 months. The mean differences between test and control s ites at 6 months were 0.71 mm and 0.56 mm PD and CAL respectively.