Clinical Research Directory

Longitudinal Evaluation of Regenerative Treatment of Peri-implantitis Assited by Er,Cr:YSGG Laser: up to 10 Years Follow-up

Sponsor: University of Guarulhos

Summary

Peri-implantitis is a pathological condition characterized by the inflammation of peri-implant connective tissues and progressive alveolar bone loss. There is a global concern about the increasing prevalence of this disease, which may affect up to 43% of implants in function. This cohort study will evaluated the long term follow up of a randomized, controlled, double-blind placebo study that evaluated the regenerative treatment of peri-implant diseases with surgical debridement and Er,Cr:YSGG AG laser associated with systemic antibiotics. A total of 80 subjects with peri-implantitis (PD\>5mm, BoP and/or sup, bone loss \>3mm) will be treated reavluated after 10years follow-up. Clinical, radiographic, and microbiological parameters will be recorded at baseline and 120 months follow-up. The primary outcome variable of this trial was be the difference between groups for the change in clinical attachment level from baseline to 6 months. We did consider composite outcomes, although not as the primary outcome. We also aim to evaluate the number and percentage of patients (and implants) reaching the following clinical endpoint for treatment: Probing depth \< 5mm, absence of bleeding on probing and no further bone loss (Heitz-Mayfield and Mombelli, 2014). The secondary variables will be the differences between groups in PI, GI, BOP, SUP and PD and microbial profile.

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