Adult periodontitis treated with a new device for subgingival lavage-a randomized controlled clinical trial using a split-mouth design

Objectives: To evaluate in patients with untreated adult periodontitis, the effect of treatment with a novel pocket irrigator/evacuator device (IED) compared to conventional subgingival debridement (CPT), both provided during the initial phase of active periodontal therapy. Methods: This study was an examiner-blind, randomized controlled clinical trial using a split-mouth design. Systemically healthy patients with adult periodontitis were selected. Full-mouth probing pocket depth (PPD), gingival bleeding on pocket probing scores (BOPP), gingival recession (REC) and dental plaque (PI) were assessed at baseline. All participants received oral hygiene instructions and supragingival prophylaxis including polishing. In 2 randomly assigned contra-lateral quadrants, approximal sites were irrigated with the IED, whereas in the other quadrants, CPT was provided. The CPT consisted of subgingival debridement using ultrasonic devices followed by the use of hand instruments. At 3 months post-treatment, the clinical parameters were re-assessed. Results: Twenty-five patients met the inclusion criteria and were willing to participate. At 3 months post-treatment, the PPD and BOPP had significantly improved for both treatment modalities. Pockets of ≥5 mm reduced by 0.64 mm in the IED group (P < .001), compared to a reduction of 0.82 mm for the CPT group (P < .001). With respect to the primary outcome parameter (PPD) and BI, the results with the IED were less pronounced. Between the test and control groups, no significant differences were observed for REC and PI. Conclusions: Oral hygiene instructions, supragingival prophylaxis and subgingival lavage with the IED resulted in a significant reduction in PPD and BOPP. However, the effect does not reach the results of CPT which included the subgingival use of ultrasonic and hand instruments.