This is a prospective, observational, multicenter study designed to evaluate the real-world efficacy and safety of H42®, a collagen hydrogel, in the treatment of periodontal pockets. The study will include 153 observations related to 38 subjects (aged 18-65) undergoing periodontal treatment in routine clinical practice. H42® is intended for filling, reinforcing, and repairing periodontal pockets.
The primary objective is to evaluate the change in Periodontal Pocket Depth (PPD) from baseline to week 12.
Secondary objectives include assessing:
* Clinical Attachment Level (CAL): Calculated as PPD minus the distance from the cemento-enamel junction (CEJ) to the free gingival margin (FGM).
* Inflammatory Indices: Sulcus Bleeding Index (SBI), Bleeding On Probing (BOP), and Gingival Index (GI).
* Plaque Control: Plaque Index (PI) using the Silness and Löe scale.
* Patient-Reported Outcomes: Pain levels via a Numeric Rating Scale (NRS 0-10) and treatment satisfaction.
* Safety: Clinical assessment of infection (suppuration), Global Safety assessed by the Investigator (IGAS), and Global Safety assessed by the Patient (PGAS).
Participants undergo a baseline visit (V1) and six follow-up visits (V2-V7) over 12 weeks:
* V1 (Baseline): Mechanical instrumentation (scaling and root planing) followed by the application of H42® hydrogel (up to 5 pockets per patient). Baseline assessments include PPD, CAL, SBI, BOP, PI, GI, NRS pain, and radiographic imaging (X-ray or CBCT).
* V2, V3, V4 (Weeks 1, 2, 3): Evaluation of GI, pain (NRS), and presence of infection/suppuration.
* V5 (Week 4) \& V6 (Week 8): Comprehensive periodontal assessment including PPD, CAL, SBI, BOP, PI, GI, and pain monitoring.
* V7 (Week 12 - End of Study): Final assessment of all periodontal parameters, radiographic imaging to measure pocket depth reduction, patient satisfaction survey, and global safety assessments (IGAS/PGAS).
Clinical photography is used throughout the study to support the evaluation of gingival inflammatory status.