Para-Probiotic Oral Care in Periodontal Patients With Type 2 Diabetes
Launched by UNIVERSITY OF PAVIA · Jul 5, 2025
Trial Information
Current as of July 24, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether using special oral care products containing “para-probiotics” can help improve gum health and blood sugar control in people with type 2 diabetes who also have gum disease (periodontitis). Para-probiotics are natural ingredients that may support a healthy balance of bacteria in the mouth. The study will compare these products to the more common chlorhexidine mouthwash and toothpaste, which are often used to treat gum problems.
Adults aged 18 to 70 with diagnosed gum disease and type 2 diabetes (for at least one year) may be eligible to join. Participants will receive standard deep cleaning treatment for their gums and then use either the para-probiotic products or chlorhexidine products twice daily for 15 days after each dental check-up. Their gum health and blood sugar levels will be checked at the start of the study, and again after 3 and 6 months. The researchers will also ask participants how satisfied they are with the treatments. This study aims to find out if para-probiotics can be a helpful, natural addition to usual gum care for people managing diabetes.
Gender
ALL
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
About University Of Pavia
The University of Pavia, a prestigious institution renowned for its commitment to academic excellence and research innovation, serves as a prominent clinical trial sponsor. With a strong emphasis on advancing medical knowledge and improving patient care, the university leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous clinical research. Collaborating with leading healthcare professionals and institutions, the University of Pavia is dedicated to exploring novel therapeutic approaches and fostering the translation of scientific discoveries into clinical practice, ultimately aiming to enhance health outcomes and contribute to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Pavia, Lombardy, Italy
Patients applied
Trial Officials
Andrea Scribante, Associate Professor
Principal Investigator
University of Pavia
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported