Non-surgical Treatment of Peri-implant Pockets With H42

This prospective, observational study evaluates the efficacy and safety of H42 non-surgical treatment for peri-implant pockets. The trial involves 56 patients, with 28 subjects receiving the H42 treatment and 28 acting as a control group to monitor soft tissue healing and bone level changes. Clinical outcomes focus on Pocket Probing Depth (PPD) and Silness and Löe Plaque Index (PI) measured at baseline, 1 month, and 3 months. Gingival inflammation, pain intensity on a 0-10 NRS scale, and absence of infection are monitored at baseline, 7, 14, and 21 days, and at 1 and 3 months. Additionally, a five-point tissue assessment evaluates color, suppuration, granulation tissue, bleeding, and incision margins. Radiographic analysis at baseline and 3 months uses standardized periapical x-rays to measure bone level, intra-bony defect height, width, and angulation. Safety is assessed through the continuous registration of adverse events.

Inclusion Criteria: * Men or women with age ≥ 25 and ≤ 65 years. * Subjects affected by peri-implant pockets with probing depth (PD) in the range between 6 to 8 mm. * Each subject can have from 1 to 5 defects. * Subjects willing to provide signed informed consent to clinical investigation participation. Exclusion Criteria: * Use of aspirin and antiplatelet agents a week before treatment. * Subjects smokers ≥ 10 cigarettes per day. * Subjects presenting current or previous bleeding disorders. * Subjects taking or having indications for anticoagulant therapy. * Concomitant treatments or procedures to improve gum health over the last six months before the clinical investigation enrolment, such as HA gel treatments, injection of fillers, and surgery. * Subjects suffering from infectious diseases, including herpes simplex infection, active hepatitis, or human immunodeficiency virus. * Subjects with dental aesthetic surgery in the preceding 12 months before the clinical investigation enrolment.