Probiotics in Special Needs Patients at High Risk for Tooth Decay: a Randomized Controlled Trial.
Launched by G. D'ANNUNZIO UNIVERSITY · Sep 26, 2023
Trial Information
Current as of July 23, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is researching whether probiotics, which are beneficial bacteria, can help prevent tooth decay in individuals with intellectual disabilities who may struggle with keeping their mouths clean. The specific probiotics being tested are Lactobacillus rhamnosus LR04 and Lactobacillus plantarum LP14. The study will include participants who have at least one decayed tooth and some gum inflammation. The main questions the researchers want to answer are if these probiotics can support tooth decay prevention and improve saliva health.
Participants in the study will be divided into three groups. One group will take the probiotics for 90 days while maintaining their usual oral hygiene routine. Another group will receive a placebo (a non-active treatment) for the same period, and the third group will only follow their regular oral hygiene without any additional treatment. This trial is not currently recruiting participants, but it aims to find out if probiotics can help improve dental health for people with special needs.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • individuals with intellectual disability in presence of gingivitis in 1 quadrant at least and 1 decayed tooth at least, and improper oral hygiene routine.
- Exclusion Criteria:
- • individuals without intellectual disability or with the condition in absence of gingivitis, decayed teeth and improper oral hygiene routine.
About G. D'annunzio University
G. D'Annunzio University, located in Chieti-Pescara, Italy, is a prominent academic institution committed to advancing scientific research and innovation in the health sciences. With a strong emphasis on interdisciplinary collaboration, the university fosters an environment that encourages the development of novel therapeutic strategies and clinical applications. As a clinical trial sponsor, G. D'Annunzio University seeks to contribute to the improvement of patient outcomes through rigorous research methodologies, ethical standards, and a focus on translational medicine. Their dedication to education and research excellence positions them as a key player in the advancement of healthcare solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chieti, , Italy
Patients applied
Trial Officials
Marco Dolci, MD DDS PHD
Principal Investigator
University G. d'Annunzio of Chieti
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported