Non-surgical Treatment of Peri-implant Pockets With H42

Recruiting now

Conditions studied: Peri-implantitis

In brief

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.

Key facts

Study ID

NCT07680491

Run by

Bioteck S.p.A.

People needed

56

Starts

2025-12-03

Expected to finish

2027-09-30

Last updated by the study team

2026-07-02

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Faculty of Dentistry, University of Seville — Seville, Spain (enrolling)

Full record on ClinicalTrials.gov

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