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Completed

NCT Number: NCT07700628

Treatment of Periodontal and Peri-Implant Pockets With a Novel Collagen Hydrogel, 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.

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Key information

Conditions

Periodontal Pocket Mouth Diseases Peri-Implantitis Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Studi Odontoiatrici Papa e Di Stefano, Caserta, CE, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

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

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

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

    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.

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

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

    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).

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

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

    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.

Secondary outcomes

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

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

    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.

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

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

    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.

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

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

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

Sponsors and collaborators

Lead sponsor

Studio Odontoiatrico Dott. G. Tarquini

Other

Registry information

Official study 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

Acronym: H42

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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