Meta-Analysis of Three Chronic PeriodontitisTrials with Periowave™ Photodisinfection

OBJECTIVES: Data from three prospective, randomized, IRB-approved clinical trials of the Periowave™ photodisinfection system for the treatment of chronic periodontitis were meta-analyzed using binary-outcome as well as continuous-variable techniques. Studies evaluated the effect of Periowave™ adjunctive to SRP (scaling and root planing) on Clinical Attachment Level (CAL), Pocket Depth (PD) and Bleeding on Probing (BOP) endpoints at 6 and 12 weeks against SRP alone. Two studies were examiner-blinded; one study additionally evaluated Periowave™ as a monotherapy; and one study additionally evaluated Periowave™ in a retreatment protocol using Periowave™ alone at 6 weeks after the initial adjunctive use with SRP.

METHODS: 178 patients with >4 pockets of PD >5-6 mm and BOP were recruited in total, with each receiving two sequential half-mouth SRP procedures. Studies were powered to detect statistically significant changes in PD. During the second visit, patients randomized to the Periowave™ arm received photodisinfection on all qualified pockets. At the 6- and 12-week follow-ups, clinical endpoints were measured using either double-pass manual probing or electronic probing. In the re-treatment study, Periowave™-randomized patients received a second photodisinfection at 6 weeks.

RESULTS: No adverse event judged to be treatment-related occurred during any of the studies. A total of 3131 pockets were included in the meta-analysis. Using continuous-variable analysis, PD reduction in the retreatment study significantly exceeded that in either the single-treatment study (p = 0.02) or in the SRP alone arms (p = 0.05). Using binary-outcome analysis, the retreatment study showed 2.3 times the number of 2+ mm pocket depth reductions over SRP alone (p < 0.0001).

CONCLUSION: The meta-analysis showed that one adjunctive Periowave™ treatment produced significantly better PD reductions than SRP alone, and that a retreatment with Periowave™ alone at 6 weeks further improved outcomes, including a 2.3 fold increase in the number of 2+ mm PD reductions.