Para-probiotic oral care for gum disease in people with type 2 diabetes
Evaluation of Para-Probiotic Toothpaste and Mouthwash on Periodontal Health and Glycemic Control in Diabetic Patients: A Randomized Controlled Trial
This trial will test whether para-probiotic toothpaste and mouthwash, used with standard non-surgical cleaning, can improve gum health and blood sugar control in adults with periodontitis and type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Pavia Academic / other |
| Locations | 1 site (Pavia, Lombardy) |
| Trial ID | NCT07069166 on ClinicalTrials.gov |
What this trial studies
This randomized, controlled trial will enroll 40 adults (age 18–70) with Stage II–III periodontitis and a diagnosis of type 2 diabetes for at least one year. All participants receive standard non-surgical periodontal therapy, and are randomly assigned to use either para-probiotic oral products (Biorepair Plus Parodontogel and Biorepair Plus mouthwash) or toothpaste and mouthwash containing 0.20% chlorhexidine twice daily for 15 days after each recall visit. Clinical exams at baseline, 3 months, and 6 months will record periodontal measures including clinical attachment level (CAL), bleeding on probing (BoP), probing pocket depth (PPD), and plaque index (PI), alongside glycemic control measured by hemoglobin A1c. The study compares changes in these periodontal and metabolic outcomes between the para-probiotic and chlorhexidine groups.
Who should consider this trial
Good fit: Adults aged 18–70 with Stage II or III periodontitis (Grade B or C), at least one periodontal pocket per side, up to 20 teeth with pathological probing depths, and a diagnosis of type 2 diabetes for at least one year who are in generally good health and can follow study procedures are ideal candidates.
Not a fit: Those without type 2 diabetes, with steroid-induced diabetes, who are pregnant or breastfeeding, who have cardiac pacemakers or significant neurological/psychiatric conditions, or who cannot follow follow-up visits or home oral care instructions are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the para-probiotic regimen could improve periodontal inflammation and modestly help blood sugar control while offering an alternative to chlorhexidine with potentially fewer side effects.
How similar studies have performed: Previous probiotic approaches for periodontal disease have shown modest improvements in inflammation and plaque, while para-probiotics (non-viable microbial components) are less extensively studied but have shown preliminary promise in small trials.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pavia, Lombardy
- Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia — Pavia, Lombardy, Italy (Recruiting)
Study contacts
- Principal investigator: Andrea Scribante, Associate Professor — University of Pavia
- Study coordinator: Andrea Scribante, Associate Professor
- Email: andrea.scribante@unipv.it
- Phone: +39 0382516223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.