Condition: Peri-implantitis · Sponsor: Bioteck S.p.A.
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.
This description comes directly from the study's public registry record.
Marco Morroni, PhD · 389 059 0480 · m.morroni@bioteck.com
Anna Di Bona, PhD · 32779983709 · a.dibona@bioteck.com
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| Faculty of Dentistry, University of Seville | Seville, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07680491