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

NCT07700628 | Completed

• 1 other identifier: H42 Protocol V.2.0, 25-Jul-15
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Periodontal Pocket; Peri-implantitis

Keywords

Peri-implantitis; Periodontitis; Collagen hydrogel; Non-surgical treatment; Soft tissues healing; Periodontal pockets; Peri-implant pockets

Outcome Measures

Primary Outcomes (4)

• Change from Baseline in Periodontal Pocket Depth (PPD) at 30 and 90 days

  PPD defined as the distance, measured in millimeters (mm) from the gingival margin to the bottom of the gingival sulcus/pocket.

  Baseline before H42 treatment; 30 days and 90 days after H42 treatment.

• Change from Baseline in Plaque Index (PI) at 30 and 90 days

  PI will be used to evaluate the presence and thickness of plaque at the gingival margin. Scoring is based on the Silness and Löe Plaque Index criteria on a scale from 0 to 3, where: 0 = no plaque; 1 = a film of plaque adhering to the free gingival margin and adjacent area of the tooth, recognized only by running a probe across the tooth surface; 2 = moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, visible to the naked eye; 3 = abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. Higher scores indicate greater plaque accumulation. The final value represents the patient's average score across all examined surfaces.

  Baseline before H42 treatment; 30 days and 90 days after H42 treatment.

• Change from Baseline in Clinical Attachment Level (CAL) at 30 and 90 days

  CAL will be evaluated to assess periodontal tissue regeneration. Measurement is calculated using the formula: CAL = PPD - (CEJ to FGM distance), where PPD is Probing Pocket Depth, CEJ is Cemento-Enamel Junction, and FGM is Free Gingival Margin. Measurements will be taken in millimeters (mm).

  Baseline before H42 treatment; 30 days and 90 days after H42 treatment.

• Change from Baseline in Sulcus Bleeding Index (SBI) at 30 ad 90 days

  SBI evaluated as ordinal variable with a scale from 0 to 5, where: 0 = gingiva of normal texture, color, no bleeding; 1 = gingiva apparently normal, bleeding on probing; 2 = bleeding on probing, color change, no edema; 3 = bleeding on probing, color change, slight edema; 4 = either bleeding on probing, color change, obvious edema; 5 = spontaneous bleeding on probing, color change.

  Baseline before H42 treatment; 30 days and 90 days after H42 treatment.

Secondary Outcomes (3)

• Change from Baseline in Patient-Reported Pain Score at five predefined follow-up timepoint

  Baseline before H42 treatment and at 7, 14, 21, 30, and 90 days after the use of H42.

• Change from baseline in inflammation grade at five predefined follow-up timepoints

  Baseline before H42 treatment and at 7, 14, 21, 30, and 90 days after the use of H42.

• Change from Baseline in soft tissue healing at five predefined follow-up timepoint

  Baseline before H42 treatment and at 7, 14, 21, 30, and 90 days after the use of H42.

Study Arms (2)

Periodontitis group

28 patients affected by periodontitis ranging from stage II to IV, classified according to the 2018 EFP/AAP new classification of Periodontal and Peri-Implant Diseases and Conditions.

Peri-implantitis group

23 patients affected by peri-implantitis with a severity grade classified according to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 in three dental clinics located in Italy.

You may qualify if:

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

You may not qualify if:

• Use of aspirin and/or antiplatelet agents one week prior to treatment.
• Smokers (≥10 cigarettes per day).
• 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.
• Subjects with infectious diseases, including infection with the herpes simplex virus, active hepatitis, or the human immunodeficiency virus.
• Subjects who have undergone cosmetic dental surgery within the previous 12 months.

Sponsors & Collaborators

• Studio Odontoiatrico Dott. G. Tarquini: lead

Study Sites (3)

Studi Odontoiatrici Papa e Di Stefano

Caserta, CE, 81100, Italy

Location

Studio Odontoiatrico Dott. G. Tarquini

Roma, RM, 00179, Italy

Location

Studio odontoiatrico Sao di De Rosa Nicola e Del Giudice Marina

Naples, 80122, Italy

Location

Related Publications (12)

• Hentenaar DFM, De Waal YCM, Van Winkelhoff AJ, Meijer HJA, Raghoebar GM. Non-surgical peri-implantitis treatment using a pocket irrigator device; clinical, microbiological, radiographical and patient-centred outcomes-A pilot study. Int J Dent Hyg. 2020 Nov;18(4):403-412. doi: 10.1111/idh.12462. Epub 2020 Sep 11.

  PMID: 32794356 BACKGROUND

• Ma L, Diao X. Effect of chlorhexidine chip as an adjunct in non-surgical management of periodontal pockets: a meta-analysis. BMC Oral Health. 2020 Sep 21;20(1):262. doi: 10.1186/s12903-020-01247-8.

  PMID: 32957945 BACKGROUND

• Rokaya D, Srimaneepong V, Wisitrasameewon W, Humagain M, Thunyakitpisal P. Peri-implantitis Update: Risk Indicators, Diagnosis, and Treatment. Eur J Dent. 2020 Oct;14(4):672-682. doi: 10.1055/s-0040-1715779. Epub 2020 Sep 3.

  PMID: 32882741 BACKGROUND

• Robitaille N, Reed DN, Walters JD, Kumar PS. Periodontal and peri-implant diseases: identical or fraternal infections? Mol Oral Microbiol. 2016 Aug;31(4):285-301. doi: 10.1111/omi.12124. Epub 2015 Sep 15.

  PMID: 26255984 BACKGROUND

• Derks J, Tomasi C. Peri-implant health and disease. A systematic review of current epidemiology. J Clin Periodontol. 2015 Apr;42 Suppl 16:S158-71. doi: 10.1111/jcpe.12334.

  PMID: 25495683 BACKGROUND

• Caton JG, Armitage G, Berglundh T, Chapple ILC, Jepsen S, Kornman KS, Mealey BL, Papapanou PN, Sanz M, Tonetti MS. A new classification scheme for periodontal and peri-implant diseases and conditions - Introduction and key changes from the 1999 classification. J Clin Periodontol. 2018 Jun;45 Suppl 20:S1-S8. doi: 10.1111/jcpe.12935.

  PMID: 29926489 BACKGROUND

• Chatzigiannidou I, Teughels W, Van de Wiele T, Boon N. Oral biofilms exposure to chlorhexidine results in altered microbial composition and metabolic profile. NPJ Biofilms Microbiomes. 2020 Mar 20;6(1):13. doi: 10.1038/s41522-020-0124-3.

  PMID: 32198347 BACKGROUND

• Loesche WJ, Grossman NS. Periodontal disease as a specific, albeit chronic, infection: diagnosis and treatment. Clin Microbiol Rev. 2001 Oct;14(4):727-52, table of contents. doi: 10.1128/CMR.14.4.727-752.2001.

  PMID: 11585783 BACKGROUND

• Kwon T, Lamster IB, Levin L. Current Concepts in the Management of Periodontitis. Int Dent J. 2021 Dec;71(6):462-476. doi: 10.1111/idj.12630. Epub 2021 Feb 19.

  PMID: 34839889 BACKGROUND

• Slots J. Periodontitis: facts, fallacies and the future. Periodontol 2000. 2017 Oct;75(1):7-23. doi: 10.1111/prd.12221.

  PMID: 28758294 BACKGROUND

• Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721.

  PMID: 29926951 BACKGROUND

• Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of severe periodontitis in 1990-2010: a systematic review and meta-regression. J Dent Res. 2014 Nov;93(11):1045-53. doi: 10.1177/0022034514552491. Epub 2014 Sep 26.

  PMID: 25261053 BACKGROUND

MeSH Terms

Conditions

Periodontal Pocket; Peri-Implantitis; Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Dental Surgery

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 14, 2026
• Study Start: June 6, 2022
• Primary Completion: January 17, 2023
• Study Completion: April 17, 2023
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)