Para-Probiotic Oral Care in Periodontal Patients With Type 2 Diabetes

Change in mean Clinical Attachment Level (CAL)

This outcome measures the difference in mean Clinical Attachment Level (CAL) between baseline and the 6-month follow-up in patients with periodontitis and type 2 diabetes mellitus, randomized to receive either para-probiotic-based or chlorhexidine-based oral care after standard non-surgical periodontal therapy. CAL will be assessed in millimeters at six sites per tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, disto-lingual) using a calibrated manual periodontal probe. Measurements will be performed at three predefined timepoints: at baseline (T0, Day 0) before the start of treatment; at three months (T1, approximately Day 90) as an intermediate evaluation; and at six months (T2, approximately Day 180), which represents the final endpoint. The primary endpoint is defined as the difference in mean CAL per patient between the baseline and the 6-month follow-up.

Change in Bleeding on Probing (BoP) score

This outcome measures the variation in Bleeding on Probing (BoP) between baseline and follow-up visits in patients receiving either para-probiotic or chlorhexidine oral care. BoP is assessed using a calibrated periodontal probe inserted into the gingival sulcus at six sites per tooth. A site is considered positive if bleeding occurs within 15 seconds of probing. The BoP score is expressed as the percentage of bleeding sites out of the total number of sites examined for each patient. Higher scores indicate a greater degree of gingival inflammation. Measurements will be recorded at baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2). The endpoint is defined as the change in mean BoP score between T0 and T2.

Change in Probing Pocket Depth (PPD) score

This outcome assesses the variation in Probing Pocket Depth (PPD) between baseline and follow-up visits in patients receiving either para-probiotic or chlorhexidine oral care. PPD is measured in millimeters using a calibrated UNC-15 periodontal probe inserted into the gingival sulcus at six sites per tooth. The depth is recorded as the distance from the gingival margin to the bottom of the periodontal pocket. The PPD score is calculated as the mean depth of all recorded sites per patient. Higher values indicate more severe periodontal involvement. Measurements will be taken at baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2). The endpoint is defined as the change in mean PPD score between T0 and T2.

Change in Plaque Index (PI) score

This outcome evaluates the variation in the Plaque Index (PI) score between baseline and follow-up in both study groups. PI is determined by visually assessing the presence of dental plaque on four surfaces per tooth (distal, mesial, buccal, and lingual/palatal) after disclosing agent application. The score is expressed as the percentage of plaque-positive sites over the total number of examined sites per patient. Higher scores indicate poorer oral hygiene and greater plaque accumulation. Measurements are collected at baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2). The endpoint is the change in mean PI score between T0 and T2.

Change in glycated hemoglobin (HbA1c) level

This outcome measures the variation in glycated hemoglobin (HbA1c) levels between baseline and follow-up in patients undergoing para-probiotic or chlorhexidine oral care. HbA1c is measured using standardized blood assays and reflects average blood glucose control over the previous 8-12 weeks. The value is expressed as a percentage of total hemoglobin. Lower values indicate better glycemic control. Measurements are performed at baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2). The endpoint is the change in mean HbA1c level between T0 and T2.