Safety and Preliminary Efficacy of a Novel Host-Modulatory Therapy for Reducing Gingival Inflammation.

Background: Periodontal disease is among the sixth most common inflammatory diseases worldwide with high risk to promote complications from other inflammatory diseases including diabetes, cardiovascular disease and Alzheimer's Disease. Failure of active resolution of inflammation pathways is implicated in pathogenesis of periodontal diseases, including gingivitis. Lipoxin A4 (LXA4), a member of the specialized pro-resolving lipid mediators (SPMs) that drive resolution of inflammation via GPC-receptor mediated pathways, offered therapeutic advantages in preclinical models of periodontitis. Methods: We conducted a randomized, placebo-controlled, parallel-group Phase 1 clinical trial to determine the safety and preliminary efficacy of an LXA4 analog in patients with gingival inflammation. One hundred twenty-seven (127) individuals were randomized to daily use of an oral rinse containing a LXA4 mimetic, methyl ester-benzo-lipoxin A4 (BLXA4), placebo rinse or a no-rinse control group for 28 days. Treatment emergent adverse events (TEAEs) were assessed for safety, the primary outcome. Secondary outcomes included the change in the level of gingival inflammation and periodontal pocket depth (PD). Serum SPMs were monitored using targeted lipid mediator lipidomics to assess potential systemic impact of BLXA4. Results: The frequency of TEAEs was similar in BLXA4 and placebo-treated groups with no study-related SAEs. Once-daily rinsing with BLXA4 for 28-days resulted in a greater decrease in gingival inflammation compared to placebo rinse and no-rinse control groups (mean change: 0.26 GI unit vs 0.21 and 0.17, respectively). PD reduction was also greater with BLXA4 oral rinse compared to placebo and no-rinse groups (mean reduction: 1.23 mm vs. 0.71 mm and 0.46 mm, respectively). Topical application of BLXA4 increased serum levels of SPMs. Conclusion: Treatment with BLXA4 reduces local inflammation, and increases abundance of pro-resolution molecules systemically, which may dampen inflammation that can mediate progression and course of inflammatory diseases beyond periodontitis. Clinical Trial Registration: ClinicalTrials.gov, identifier (NCT02342691).

Comparison of the impact of scaler material composition on polished titanium implant abutment surfaces.

PURPOSE: The purpose of this study was to compare the impact of the removal of biofilm with hand scalers of different material composition on the surface of implant abutments by assessing the surface topography and residual plaque after scaling using scanning electron microscopy (SEM). METHODS: Titanium implant analogs from 3 manufacturers (Straumann USA LLC, Andover, Maine, Nobel BioCare USA LLC, Yorba Linda, Cali, Astra Tech Implant Systems, Dentsply, Mölndal, Sweden) were mounted in stone in plastic vials individually with authentic prosthetic abutments. Plaque samples were collected from a healthy volunteer, inoculated into growth medium and incubated with the abutments anaerobically for 1 week. A blinded, calibrated hygienist performed scaling to remove the biofilm using 6 implant scalers (in triplicate), 1 scaler for 1 abutment. The abutments were mounted on an imaging stand and processed for SEM. Images were captured in 3 randomly designated areas of interest on each abutment. Analysis of the implant polished abutment surface and plaque area measurements were performed using ImageJ image analysis software. Surface alterations were characterized by the number, length, depth and the width of the scratches observed. RESULTS: Glass filled resin scalers resulted in significantly more and longer scratches on all 3 abutment types compared to other scalers, while unfilled resin scalers resulted in the least surface change (p < 0.05). Filled resin-graphite reinforced scalers, carbon fiber reinforced resin scalers and titanium scalers resulted in more superficial scratches compared to glass filled resin, as well as more scratches than unfilled resin. No statistically significant differences were found between scalers and abutments with regard to plaque removal. CONCLUSION: The impact of scalers on implant abutment surfaces varies between abutment types presumably due to different surface characteristics with no apparent advantage of one abutment type over the other with regard to resistance to surface damage. Unfilled resin was found consistently to be the least damaging to abutment surfaces, although all scalers of all compositions caused detectable surface changes to polished surfaces of implant abutments.