NCT07069166 Para-Probiotic Oral Care in Periodontal Patients With Type 2 Diabetes
| NCT ID | NCT07069166 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pavia |
| Condition | Periodontitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-07-30 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-07-30 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Age between 18 and 70 years * Diagnosis of periodontitis (Stage II or III; Grade B or C) * Presence of at least one periodontal pocket per side of the mouth, with a maximum of 20 teeth presenting pathological probing depths * Presence of both single- and multi-rooted teeth * Type 2 diabetes mellitus diagnosed at least one year prior to enrollment * Good general health status and ability to comply with study protocol * Written informed consent provided Exclusion Criteria: * Presence of cardiac pacemakers * History of neurological disorders * History of psychiatric disorders * Current pregnancy or breastfeeding * Steroid-induced diabetes mellitus * Inability or unwillingness to attend follow-up visits or adhere to home oral care instructions
Contact & Investigator
Andrea Scribante, Associate Professor
PRINCIPAL INVESTIGATOR
University of Pavia
Frequently Asked Questions
Who can join the NCT07069166 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Periodontitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07069166 currently recruiting?
Yes, NCT07069166 is actively recruiting participants. Contact the research team at andrea.scribante@unipv.it for enrollment information.
Where is the NCT07069166 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT07069166 clinical trial?
NCT07069166 is sponsored by University of Pavia. The principal investigator is Andrea Scribante, Associate Professor at University of Pavia. The trial plans to enroll 40 participants.