Clinical, microbiologic, and biochemical effects of subgingival administration of a Xanthan-based chlorhexidine gel in the treatment of periodontitis: a randomized multicenter trial.
BACKGROUND: The use of locally delivered antibacterials containing chlorhexidine (CHX) was proposed to improve the effectiveness of non-surgical periodontal treatment. The present multicenter randomized study investigated the effects of a xanthan-based chlorhexidine (Xan-CHX) gel used as an adjunct to scaling and root planing (SRP) in the treatment of chronic periodontitis. METHODS: Ninety-eight systemically healthy subjects with moderate to advanced periodontitis were recruited in four centers (59 females and 39 males; aged 24 to 58 years). For each subject, two experimental sites located in two symmetric quadrants were chosen with probing depths (PD) >or=5 mm and positive for bleeding on probing (BOP). These two sites were randomized at the split-mouth level with one receiving a single SRP treatment and the other receiving a single SRP + Xan-CHX gel treatment. Supragingival plaque, modified gingival index, PD, clinical attachment level (CAL), and BOP were evaluated at baseline (prior to any treatment) and after 3 and 6 months. At the same times, subgingival microbiologic samples and gingival crevicular fluid (GCF) were collected for the analysis of total bacterial counts (TBCs), including the identification of eight putative periodontopathogens, and alkaline phosphatase (ALP) activity, respectively. RESULTS: The Xan-CHX treatment group showed greater improvements compared to the SRP group for PD and CAL at 3 and 6 months (P <0.001). The differences in PD reduction between the treatments were 0.87 and 0.83 mm at 3 and 6 months, respectively (P <0.001); for CAL, these were 0.94 and 0.90 mm, respectively (P <0.001). Similar behavior was seen when the subgroup of pockets >or=7 mm was considered. The percentage of sites positive for BOP was similar between the treatments at each time point. For the comparisons between the treatment groups, no differences were seen in the TBCs and GCF ALP activity at baseline and 6 months; in contrast, slightly, but significantly, lower scores were recorded for the Xan-CHX treatment group at 3 months (P = 0.018 and P = 0.045, respectively). Moreover, greater reductions in the percentages of sites positive for the eight putative periodontopathic bacteria were generally seen for the Xan-CHX treatment group compared to SRP alone. CONCLUSIONS: The adjunctive use of Xan-CHX gel promoted greater PD reductions and CAL gains compared to SRP alone. These results were concomitant with better microbiologic and biochemical outcomes when Xan-CHX gel use was added to SRP, particularly up to 3 months after treatment.