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

Bioteck S.p.A.38 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Periodontal Pocket

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary Outcomes

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).

Time frame: Baseline, Week 4, Week 8, Week 12

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.

Time frame: Baseline, Week 4, Week 8, Week 12

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.

Time frame: Baseline, Week 4, Week 8, Week 12

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.

Time frame: Baseline, Week 4, Week 8, Week 12

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.

Time frame: Baseline, Weeks 1, Weeks 2, Week 4, Week 8, Week 12

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.

Time frame: Baseline, Weeks 1, Weeks 2, Week 4, Week 8, Week 12

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.

Time frame: Week 12

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.

Time frame: Week 12

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.

Time frame: Baseline, Week 12

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.

Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, and Week 12

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes