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Search / Trial NCT07069166

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 23, 2025

Not yet recruiting

Keywords

Para Probiotics Periodontitis Type 2 Diabetes Mellitus Biorepair Oral Microbiota Glycated Hemoglobin (Hb A1c) Chlorhexidine Non Surgical Periodontal Therapy Randomized Controlled Trial

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.

Locations

Pavia, Lombardy, Italy

Patients applied

0 patients applied

Trial Officials

Andrea Scribante, Associate Professor

Principal Investigator

University of Pavia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported