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Search / Trial NCT06063239

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

Caries; Tooth Decay Intellectual Disability Probiotics Lactobacillus Rhamnosus Lactobacillus Plantarum P H

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.

Locations

Chieti, , Italy

Patients applied

0 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