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

Treatment of Periodontal and Peri-Implant Pockets With a Novel Collagen Hydrogel: A Multicenter Retrospective Study on the Clinical Use of the H42 Medical Device

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.

Inclusion Criteria:

1. Adults aged 25 years ≤ age ≤ 65 years.
2. Subjects with peri-implant or periodontal pockets with probing depths (PD) between 5 and 8 mm.
3. Subjects with 1-5 defects.
4. Subjects willing to provide signed informed consent to participate in the clinical study.

Exclusion Criteria:

1. Use of aspirin and/or antiplatelet agents one week prior to treatment.
2. Smokers (≥10 cigarettes per day).
3. Use of concomitant treatments or procedures aimed at improving gum health within the last six months prior to enrollment in the clinical trial, such as treatments with HA gel, filler injections, or surgical procedures.
4. Subjects with infectious diseases, including infection with the herpes simplex virus, active hepatitis, or the human immunodeficiency virus.
5. Subjects who have undergone cosmetic dental surgery within the previous 12 months.