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

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.