No phaseCompleted
Para-Probiotic Oral Care in Periodontal Patients With Type 2 Diabetes (PPDM2)
Evaluation of Para-Probiotic Toothpaste and Mouthwash on Periodontal Health and Glycemic Control in Diabetic Patients: A Randomized Controlled Trial
- Sponsor
- University of Pavia (Academic or other)
- Enrolment
- 40 enrolled
- Conditions
- Periodontitis; Type 2 Diabetes Mellitus (T2DM)
- Interventions
- Para-probiotic oral care; Chlorhexidine oral care
- Ages
- adults, older adults
- Registry
- NCT07069166
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Change in mean Clinical Attachment Level (CAL)
History
Last registry update
Study completion
Primary completion
Started
Registered