Clinical Trial

Treatment of Periodontal and Peri-Implant Pockets With a Novel Collagen Hydrogel, H42 Medical Device

Study acronym: H42
Completed
View on ClinicalTrials.gov →
Summary
A retrospective, observational, non-profit study designed to evaluate the use of the H42 medical device in patients with periodontitis or peri-implantitis. The study included adult subjects aged 25 to 65 years with peri-implant or periodontal pockets with probing depths (PD) between 5 and 8 mm and 1-5 defects, treated with H42® according to standard clinical practice. The primary outcome involved comparing the periodontal parameters-Periodontal Pocket Depth (PPD), Plaque Index (PI), Clinical Attachment Level (CAL), and Sulcus Bleeding Index (SBI)-before the application of H42 (baseline) and at follow-up visits after 30 and 90 days. The secondary outcomes, on the other hand, assessed soft tissue healing, pain levels via Numeric Rating Scale (NRS 0-10), recurrence of infection, and any unexpected side effects observed. These parameters were assessed at 7, 14, 21, 30, and 90 days after the use of H42.
Trial Details
NCT Number NCT07700628
Lead Sponsor Studio Odontoiatrico Dott. G. Tarquini
Conditions Periodontal Pocket, Peri-implantitis
Enrollment 52 participants
Start Date 2022-06-06
Primary Completion 2023-01-17 (estimated)
Study Completion 2023-04-17 (estimated)
Updated on ClinicalTrials.gov 2026-07-14