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.

Adult patients diagnosed with peri-implantitis and treated at the Department of Stomatology, Faculty of Dentistry, University of Seville, Spain. Participants are recruited from patients seeking care at the university dental clinic and are allocated to the study groups according to the study protocol and predefined inclusion and exclusion criteria. The study evaluates the adjunctive use of H42 hydrogel in the non-surgical treatment of peri-implantitis using a case-control design.