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Multicenter Study on the Use of a Collagen-based Hydrogel for the Treatment of 153 Periodontal Pockets in 38 Adults With Generalized Stage III Periodontitis

NCT07592377 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2026-05-18

No results posted yet for this study

Summary

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.

Conditions

  • Periodontal Pocket
  • Periodontitis

Interventions

DEVICE

H42® Collagen Hydrogel for the non-surgical treatment of periodontal pockets

Application of H42® collagen hydrogel for filling, reinforcing, and repairing periodontal pockets. Following standard mechanical instrumentation (scaling and root planing), the hydrogel is applied to a maximum of 5 periodontal pockets per patient (153 total pockets). The treatment is part of routine clinical practice to evaluate its real-world efficacy and safety over a 12-week period.

Sponsors & Collaborators

  • Bioteck S.p.A.

    lead INDUSTRY

Principal Investigators

  • Marisa Roncati, Dental Degree · Studio Parma Benfenati Corso della Giovecca 155/a 44121 - Ferrara (Italy)

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-12
Primary Completion
2024-12-20
Completion
2024-12-20

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07592377 on ClinicalTrials.gov