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

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.

NCT Number	NCT07104760
Lead Sponsor	University of Guarulhos
Conditions	Peri-Implantitis and Peri-implant Mucositis, Peri-Implantitis and Systemic Inflammation
Enrollment	80 participants
Start Date	2025-07-29
Primary Completion	2025-11-01 (estimated)
Study Completion	2026-10-10 (estimated)
Updated on ClinicalTrials.gov	2025-11-25