Non-surgical Treatment of Peri-implant Pockets With H42
Bioteck S.p.A.
56 participants
Dec 3, 2025
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria7
- 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.
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07680491