Non-surgical Treatment of Peri-implant Pockets With H42
- Peri-implantitis
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Bioteck S.p.A.
- Enrolment target
- 56
- Started
- 3 December 2025
- Main results due
- 30 September 2027
- Study sites
- 1
- Registry updated
- 29 September 2026
Can you take part?
- Ages 25 years to 65 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
Faculty of Dentistry, University of Seville
Seville, Spain
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07680491. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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