Outcome variables
Bleeding, PD, bleeding, tooth
BLEEDING, PLAQUE, ADVERSE EFFECTS, PLAQUE, BLEEDING
One blinded and calibrated examiner, different from the operator, performed all measurements. This examiner, before beginning the study, carried out a calibration session on five randomly selected patients, resulting in mean differences between repeated measurements of 0.5 mm for PD, with an intra-examiner reproducibility of 98% and 81% for differences ±1 and ±0.5 mm, respectively. The clinical measurements were performed in all teeth at 6 sites per tooth at baseline, 3 and 6 months. The changes in the following outcome variables were calculated:Primary outcome• PD, defined as the distance between the gingival margin (GM) and the bottom of the periodontal pocket. PD was recorded with a manual probe (UNC-15, Hu-Friedy, Chicago, IL USA) using a light force and measured to the closest millimetre.Secondary outcomes• Recession (REC), defined as the distance between the GM and the cemento-enamel junction (CEJ) or the margin of the restoration.• Clinical attachment level (CAL) calculated as the distance between the CEJ and the bottom of the periodontal pocket.• Bleeding on probing (BOP), defined as the percentage of sites positive to bleeding within 10 s after probing (%).• Plaque index (PI), defined as the percentage of sites with plaque on the tooth surface (%).• Patient-reported outcome measures (PRPMs), which include the incidence of adverse effects, and the assessment of intraoperative and postoperative discomfort by means of questionnaires.