Actively Recruiting
Para-Probiotic Oral Care in Periodontal Patients With Type 2 Diabetes
Led by University of Pavia · Updated on 2026-02-20
40
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Para-Probiotic Oral Care in Periodontal Patients With Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Diagnosis of periodontitis (Stage II or III; Grade B or C)
- At least one periodontal pocket per side of the mouth
- Maximum of 20 teeth with pathological probing depths
- Presence of single- and multi-rooted teeth
- Type 2 diabetes diagnosed at least 1 year before enrollment
- Good general health and ability to follow the study protocol
- Provided written informed consent
You will not qualify if you...
- Presence of cardiac pacemakers
- History of neurological disorders
- History of psychiatric disorders
- Currently pregnant or breastfeeding
- Steroid-induced diabetes mellitus
- Unable or unwilling to attend follow-up visits or follow home oral care instructions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, Italy, 27100
Actively Recruiting
Research Team
A
Andrea Scribante, Associate Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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