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Periodontal PocketNCT07592377

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

An observational study of Periodontal Pocket and Periodontitis, run by Bioteck S.p.A. at 2 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

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Periodontal Pocket, Periodontitis
What is being tested?
H42® Collagen Hydrogel for the non-surgical treatment of periodontal pockets
Type of treatment
Medical device
How many people
38 participants
Where
2 sitesItaly
Study dates
12 Feb 2024to 20 Dec 2024
How long will I take part?
12 Weeks
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • Studio Brecodent

    Dongo, Como, 22014

  • Studio Parma Benfenati

    Ferrara, Ferrara, 44121

Other trials in Italy

About this study

Official title: Prospective, Observational, Real World Evidence, Multicenter Study on the Use of H42® Collagen-based Hydrogel for the Treatment of Periodontal Pockets

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.

Read more

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.

Being tested
H42® Collagen Hydrogel for the non-surgical treatment of periodontal pockets
Keywords
Dental Scaling, Root Planing, Hydrogels, Collagen, Biocompatible Materials, Wound Healing, Inflammation, Prospective Studies, Multicenter Study
Medical subject headings
Periodontal Pocket, Periodontitis, Inflammation

What participants receive

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

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

    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.

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 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.

    Measured: Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary outcomes (10)

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

    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, Week 4, Week 8, Week 12

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

    SBI will be used to assess gingival inflammation. Scoring is based on Mühlemann and Son (1971) criteria on a scale from 0 to 5, where: 0 = normal texture and color, no bleeding; 1 = apparently normal, bleeding on probing; 2 = bleeding on probing, color change, no edema; 3 = bleeding on probing, color change, slight edema; 4 = bleeding on probing, color change, obvious edema (or bleeding on probing and obvious edema); 5 = bleeding on probing, spontaneous bleeding, color change, and marked edema. Higher scores indicate greater inflammation.

    Measured: Baseline, Week 4, Week 8, Week 12

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

    BOP will be assessed to evaluate the extent of periodontal inflammation. Bleeding will be recorded as present (1) or absent (0) within 15 seconds following pocket probing. The Full-Mouth Bleeding Score (FMBS) will be calculated as a percentage using the formula: (number of bleeding sites / total number of evaluated sites) x 100. Values range from 0% to 100%, with lower percentages indicating better periodontal health.

    Measured: Baseline, Week 4, Week 8, Week 12

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

    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, Week 4, Week 8, Week 12

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

    GI will be assessed to evaluate the severity and qualitative changes of gingival inflammation. Scoring is based on the Löe and Silness Gingival Index criteria on a 4-point scale from 0 to 3, where: 0 = normal gingiva; 1 = mild inflammation, slight change in color, slight edema, no bleeding on probing; 2 = moderate inflammation, redness, edema, and glazing, bleeding on probing; 3 = severe inflammation, marked redness and edema, ulceration, tendency to spontaneous bleeding. Higher scores indicate more severe gingival inflammation.

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

  6. Change from Baseline in Patient-Reported Pain Score at Weeks 1, 2, 4, 8, and 12

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

  7. Investigator Global Assessment of Performance (IGAP) at Week 12

    Global Performance of the tested device as assessed by the Investigator (IGAP) through visual evaluation of standardized photographs taken during clinical visits. The evaluation is rated using a 4-point Likert scale: 1 = very good performance; 2 = good performance; 3 = moderate performance; 4 = poor performance. Higher scores indicate worse performance or lower efficacy of the tested device.

    Measured: Week 12

  8. Patient Degree of Satisfaction at Week 12

    Patient self-reported degree of satisfaction with the treatment/device, evaluated through a 4-point satisfaction scale. The response options are defined as follows: 1 = very satisfied; 2 = satisfied; 3 = moderately satisfied; 4 = not satisfied. Higher scores indicate lower patient satisfaction.

    Measured: Week 12

  9. Change from Baseline in radiographic Periodontal Pocket Depth at Week 12

    Radiographic evaluation to assess the change from baseline to Week 12 in parameters related to the periodontal pocket depth. Measurements will be performed on standardized intraoral radiographs to quantify the vertical bone loss or defect associated with the pocket.

    Measured: Baseline, Week 12

  10. Percentage of participants with absence of infection (Suppuration) from Week 1 to Week 12

    Clinical evaluation to assess the absence of infection, specifically defined as the absence of suppuration (pus formation), at the treated site as evaluated by the Investigator. The presence or absence of suppuration will be assessed at each post-baseline visit. Results will be expressed as the percentage of participants achieving complete absence of suppuration compared to baseline.

    Measured: Baseline, Week 1, Week 2, Week 3, Week 4, and Week 12

Timeline

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

  1. First posted18 May 2026
  2. Study start12 Feb 2024
  3. Primary completion20 Dec 2024
  4. Study completion20 Dec 2024

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
Prospective
Enrolment
38 participants (actual)
Target duration
12 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT07592377
Sponsor's protocol ID
Bioteck-PeriPRO BIOT0001
Status last verified
Sep 2026
First submitted
8 May 2026
Last updated
1 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schwartz, G. Estimating the Dimension of the Model. Ann Sturist 1978; 6:461-464.

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

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

  • 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

  • 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.

    PubMed 35102150

  • 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.

    PubMed 31878278

  • 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.

    PubMed 14121956

  • 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.

    PubMed 14158464

  • 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.

    PubMed 5315729

  • 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.

    PubMed 26846817

  • 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.

    PubMed 29926943

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontal Pocket and Periodontitis, run by Bioteck S.p.A. at 2 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 8 inclusion and 10 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 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 12 weeks following application of H42® hydrogel in 153 periodontal pockets (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks). 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 NCT07592377, which also lists 11 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 1 Oct 2026.

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