Non-surgical Treatment of Peri-implant Pockets With H42

Sponsor
Bioteck S.p.A.
Study ID
NCT07680491
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 65 Years
Healthy Volunteers
Not accepted

Study Details

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 Dates

First listed
Jul 2, 2026
Start date
Dec 3, 2025
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
56 participants (estimated)

Arms

  • Arm: H42 treated group
    28 patients treated with ultrasonic treatment and manual curettes + H42®
  • Arm: Control group
    28 patients only with ultrasonic treatment and manual curettes

Primary Outcome Measure

Pocket Probing Depth (PPD) [ Time Frame: At 1 month and 3 months in comparison with the baseline value ]

Central Contacts

Related Studies