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 | Completed

• 1 other identifier: Bioteck-PeriPRO BIOT0001
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 2

Brief 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

Periodontitis; Periodontal Pocket

Keywords

Dental Scaling; Root Planing; Hydrogels; Collagen; Biocompatible Materials; Wound Healing; Inflammation; Prospective Studies; Multicenter Study

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Periodontal Pocket Depth (PPD) at 12 weeks following application of H42® hydrogel in 153 periodontal pockets

  Evaluation of the reduction in PPD, measured in millimeters (mm), from baseline to week 12. The H42® collagen hydrogel is applied to 153 periodontal pockets immediately following mechanical instrumentation for the removal of biofilm and mineralized deposits. The change is calculated as the difference between the measurement at the 12-week follow-up and the baseline value recorded.

  Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary Outcomes (10)

• Change from Baseline in Clinical Attachment Level (CAL) at Weeks 4, 8, and 12

  Baseline, Week 4, Week 8, Week 12

• Change from Baseline in Sulcus Bleeding Index (SBI) at Weeks 4, 8, and 12

  Baseline, Week 4, Week 8, Week 12

• Change from Baseline in Percentage of Bleeding on Probing (BOP) sites at Weeks 4, 8, and 12

  Baseline, Week 4, Week 8, Week 12

• Change from Baseline in Plaque Index (PI) at Weeks 4, 8, and 12

  Baseline, Week 4, Week 8, Week 12

• Change from Baseline in Gingival Index (GI) at Weeks 1, 2, 3, 4, and 12

  Baseline, Weeks 1, Weeks 2, Week 4, Week 8, Week 12

Interventions

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

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The dataset includes 153 observations related to 38 subjects, with multiple observations per subject due to different tooth positions. The study was conducted in two dental clinics located in Italy.

You may qualify if:

• Men or women with age between 18 and 65 years.
• Stage 3 generalized periodontitis
• Subjects affected by periodontal pockets with probing depth (PD) in the range between 5 to 8 mm
• For each subject a maximum of 5 defects were evaluated. If the patient presented more defects, at the beginning of the study the investigator identified the "target" lesions.
• Subjects who followed in the previous two weeks instructions to oral hygiene (proper brushing techniques twice a day, proper flossing technique daily).
• Subjects able to communicate adequately with the Investigator and to comply with the requirements for the entire study.
• The decision to prescribe H42® as an adjunctive therapy for the condition was entirely independent of that of including the patient in the study.
• Subjects or legal representatives had to be willing and able to give informed consent/assent for participation in the study.

You may not qualify if:

• Subjects presenting current or previous bleeding disorders.
• Subjects taking or having indications for anticoagulant therapy.
• Use of aspirin and antiplatelet agents within one week prior to treatment.
• Subjects with history of allergy or hypersensitivity to the tested device or to its ingredients, or hypersensitivity skin reaction to the investigational device, or at risk in term of precautions, warnings and contra-indications referred in the package insert of the clinical investigation device.
• Use of concomitant treatments or procedures aimed to improve gums health over the last six months before the clinical investigation enrolment, such as HA gel treatments, injection of fillers, surgery.
• Subjects unlikely to cooperate in the clinical investigation or with the clinical investigation visits.
• Pregnant or lactating women, or women of childbearing potential planning a pregnancy during the study.
• Subjects with illness, or other medical condition that, in the opinion of the investigator, would have compromised participation, or that would likely have resulted in hospitalization during the study (e.g., epilepsy), or predisposed to infections (e.g. HIV infection, acute hepatitis), or jeopardized the evaluation of the study results (e.g. herpes virus infection).
• Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
• Any reason, according to Investigator's judgement, able to compromise compliance with procedures outlined in the study protocol or making participation in the study not advisable, was considered.

Sponsors & Collaborators

• Bioteck S.p.A.: lead

Study Sites (2)

Studio Brecodent

Dongo, Como, 22014, Italy

Location

Studio Parma Benfenati

Ferrara, Ferrara, 44121, Italy

Location

Related Publications (11)

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  BACKGROUND

• Akaike, H. A Bayesian Analysis of the Minimum AIC Procedure. Ann Insr Stutisr Murh Part A 1978; 30: Q-14.

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• Periodontology, A. A. P. (2001). Glossary of periodontal terms. Chicago (IL): The American Academy of Periodontology.

  BACKGROUND

• Spiegelhalter, D. J., Abrams, K. R., & Myles, J. P. (2004). Bayesian Approaches to Clinical Trials and Health-Care Evaluation. John Wiley & Sons. DOI:10.1002/0470092602

  BACKGROUND

• Chung HM, Park JY, Ko KA, Kim CS, Choi SH, Lee JS. Periodontal probing on digital images compared to clinical measurements in periodontitis patients. Sci Rep. 2022 Jan 31;12(1):1616. doi: 10.1038/s41598-021-04695-6.

  PMID: 35102150 BACKGROUND

• Levrini L, Paracchini L, Nosotti MG. The Capacity of Periodontal Gel to Occupy the Spaces Inside the Periodontal Pockets Using Computational Fluid Dynamic. Dent J (Basel). 2019 Dec 24;8(1):1. doi: 10.3390/dj8010001.

  PMID: 31878278 BACKGROUND

• LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

  PMID: 14121956 BACKGROUND

• SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

  PMID: 14158464 BACKGROUND

• Muhlemann HR, Son S. Gingival sulcus bleeding--a leading symptom in initial gingivitis. Helv Odontol Acta. 1971 Oct;15(2):107-13. No abstract available.

  PMID: 5315729 BACKGROUND

• Barbosa VL, Angst PD, Finger Stadler A, Oppermann RV, Gomes SC. Clinical attachment loss: estimation by direct and indirect methods. Int Dent J. 2016 Jun;66(3):144-9. doi: 10.1111/idj.12218. Epub 2016 Feb 5.

  PMID: 26846817 BACKGROUND

• Jepsen S, Caton JG, Albandar JM, Bissada NF, Bouchard P, Cortellini P, Demirel K, de Sanctis M, Ercoli C, Fan J, Geurs NC, Hughes FJ, Jin L, Kantarci A, Lalla E, Madianos PN, Matthews D, McGuire MK, Mills MP, Preshaw PM, Reynolds MA, Sculean A, Susin C, West NX, Yamazaki K. Periodontal manifestations of systemic diseases and developmental and acquired conditions: Consensus report of workgroup 3 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S237-S248. doi: 10.1002/JPER.17-0733.

  PMID: 29926943 BACKGROUND

MeSH Terms

Conditions

Periodontal Pocket; Periodontitis; Inflammation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marisa Roncati, Dental Degree

  Studio Parma Benfenati Corso della Giovecca 155/a 44121 - Ferrara (Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 18, 2026
• Study Start: February 12, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)