- PPD is defined as the distance from the gingival margin to the base of the gingival crevice and it will be measured at six sites per tooth (DV, V, MV, DL, L, ML), using a Williams periodontal probe. Only the pockets from 5 to 8 mm depth will be taken into account. PPD will be evaluated at week 4, 8, and 12 in comparison with baseline value (visit 1).
- Collection of AE, SAE, ADE, SADE, DD.
- CAL, defined as the distance from the Cemento-Enamel Junction (CEJ) to the base of the probable crevice/pocket, and evaluated at week 4, 8 and 12 in comparison with baseline value (visit 1).
- SBI measured from four gingival units (mesial and distal papillary units and labial and lingual marginal units), using a periodontal probe with a 0.5 mm diameter tip. The scoring range around eight anterior teeth (four maxillary and four mandibular) is from 0 (healthy appearance and no bleeding on probing) to 5 (spontaneous bleeding with a marked swelling, and a change in colour). SBI will be evaluated at week 4, 8 and 12 in comparison with baseline value (visit 1).
- BOP, defined as presence/absence of bleeding within 15 seconds following pocket probing, is measured at week 4, 8 and 12 in comparison with baseline value (visit 1).
- PLI is measured for each tooth using the four-point scale Silness and Löe Plaque Index and will be evaluated at week 4, 8 and 12 in comparison with baseline value (visit 1).
- The Global Aesthetic Improvement Scale (GAIS) score assessed by the Investigator at week 4, 8, and 12 in comparison with Visit 1 (day 0).
- The degree of satisfaction with the treatment on a four-point scale (very satisfied, satisfied, moderate satisfied or not satisfied) assess the patient at week 4, 8, and 12 in comparison with Visit 1 (day 0).
- The degree of inflammation of the gingiva, the pain and the absence of infection evaluated by Investigator using VAS (0-10).
- The global performance of the tested device assessed by Investigator (IGAP) through photos taken at each visit, at weeks 4, 8 and 12, compared to Visit 1 (day 0).
- The global safety of the tested device assessed by Investigator (IGAS) and by the patient (PGAS) at weeks 12.