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Periodontal PocketH42NCT07700628

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

An observational study of Periodontal Pocket and Peri-implantitis, run by Studio Odontoiatrico Dott. G. Tarquini at 3 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Periodontal Pocket, Peri-implantitis
Type of treatment
Injection or infusion
How many people
52 participants
Where
3 sitesItaly
Study dates
6 Jun 2022to 17 Apr 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

Italy3 sites
  • Studi Odontoiatrici Papa e Di Stefano

    Caserta, CE, 81100

  • Studio odontoiatrico Sao di De Rosa Nicola e Del Giudice Marina

    Naples, 80122

  • Studio Odontoiatrico Dott. G. Tarquini

    Roma, RM, 00179

Other trials in Italy

About this study

Official title: 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.

Keywords
Peri-implantitis, Periodontitis, Collagen hydrogel, Non-surgical treatment, Soft tissues healing, Periodontal pockets, Peri-implant pockets
Medical subject headings
Periodontal Pocket, Peri-Implantitis, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07700628
Study groupRoleWhat they receive
Periodontitis group28 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 group23 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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).

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

  4. 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.

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

Secondary outcomes (3)
  1. Change from Baseline in Patient-Reported Pain Score at five predefined follow-up timepoint

    Patient-reported pain will be assessed using an 11-point Numeric Rating Scale (NRS). The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst possible pain". Higher scores represent greater pain intensity.

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

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

    Inflammation was assessed using the Gingival Index (GI), a scale ranging from 0 to 3, where GI = 0 indicates the absence of inflammation, GI = 1 indicates mild inflammation, GI = 2 indicates moderate inflammation, and GI = 3 indicates severe inflammation. Higher scores indicate greater nflammation.

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

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

    Soft tisssue healing was assessed using a scale ranging from 0 to 3, where 0 indicates the absence of healing, 3 indicates severe healing.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2026
  2. Study start6 Jun 2022
  3. Primary completion17 Jan 2023
  4. Study completion17 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07700628
Sponsor's protocol ID
H42 Protocol V.2.0, 25-Jul-15
Acronym
H42
Status last verified
Jul 2026
First submitted
25 Jun 2026
Last updated
14 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32794356
  • 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.

    PubMed 32957945
  • 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.

    PubMed 32882741
  • 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.

    PubMed 26255984
  • 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.

    PubMed 25495683
  • 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.

    PubMed 29926489
  • 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.

    PubMed 32198347
  • 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.

    PubMed 11585783
  • 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.

    PubMed 34839889
  • Slots J. Periodontitis: facts, fallacies and the future. Periodontol 2000. 2017 Oct;75(1):7-23. doi: 10.1111/prd.12221.

    PubMed 28758294
  • 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.

    PubMed 29926951
  • 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.

    PubMed 25261053

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontal Pocket and Peri-implantitis, run by Studio Odontoiatrico Dott. G. Tarquini at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Periodontal Pocket Depth (PPD) at 30 and 90 days (time frame: Baseline before H42 treatment; 30 days and 90 days after H42 treatment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07700628, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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