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

Condition(s) studied

Investigational drug(s) / intervention(s)

Para-probiotic oral care: This intervention includes the home use of a para-probiotic-based toothpaste (Biorepair Plus Parodontogel) and mouthwash (Biorepair Plus with para-probiotics), applied twice daily for 15 days after each recall visit, over a 6-month period. The products contain microRepair® (zinc hydroxyapatite), lactoferrin, zinc PCA, and para-probiotic extracts aimed at modulating the oral microbiota and improving periodontal health.

Chlorhexidine oral care: This intervention includes the home use of toothpaste and mouthwash containing 0.20% chlorhexidine digluconate, applied twice daily for 15 days after each recall visit, over a 6-month period. Chlorhexidine is used for its antimicrobial properties to control dental plaque and gingival inflammation.

Study summary

This randomized controlled clinical trial aims to evaluate the effectiveness of a para-probiotic-based oral care protocol in improving periodontal health and glycemic control in patients with type 2 diabetes mellitus (T2DM).

A total of 40 adult patients (aged 18-70) with diagnosed periodontitis and T2DM will be enrolled and randomly assigned to two treatment groups. Both groups will receive standard non-surgical periodontal therapy. The test group will use para-probiotic toothpaste and mouthwash (Biorepair Plus Parodontogel and Biorepair Plus mouthwash) twice daily for 15 days after each recall visit, while the control group will use toothpaste and mouthwash containing 0.20% chlorhexidine on the same schedule.

Clinical evaluations will be conducted at baseline (T0), 3 months (T1), and 6 months (T2), assessing key periodontal parameters including clinical attachment level (CAL), bleeding on probing (BoP), probing pocket depth (PPD), plaque index (PI), and glycemic control via hemoglobin A1c (HbA1c) levels. Patient satisfaction with treatment will be assessed using a questionnaire at T1 and T2.

The primary objective is to evaluate the change in CAL from baseline to 6 months. Secondary objectives include the evaluation of changes in BoP, PPD, PI, HbA1c, and patient-reported satisfaction.

This study seeks to determine whether para-probiotic oral care products can offer clinical benefits for periodontal disease management and systemic glycemic control in diabetic patients, potentially serving as a natural adjunct to conventional periodontal therapy.

Eligibility

Primary outcome measure(s)

• Change in mean Clinical Attachment Level (CAL) — Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)
  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.

Trial sites (1)

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