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Probiotics in Special Needs Patients at High Risk for Tooth Decay: a Randomized Controlled Trial.

NCT06063239 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-10-04

No results posted yet for this study

Summary

The goal of this randomized clinical trial is to test the effect orally administration of Probiotics based on Lactobacillus rhamnosus LR04 and Lactobacillus plantarum LP14 as adjuvant in caries prevention in subjects who can not properly perform oral hygiene procedures. The main questions it aims to answer are:

* QUESTION 1: orally administered probiotics based on the previous strains could represent a useful tool in support of special needs patients in tooth decay prevention?
* QUESTION 2: orally administered probiotics based on the previous strains could ameliorate salivary pH management?

Partecipants in the test group will take the test probiotic for 90 days in adjunction of the routinary oral hygiene procedures.

Partecipants in the positive controlled group will take the placebo for 90 days in adjunction of the routinary oral hygiene procedures.

Partecipants in the negative control group will perform only the routinary oral hygiene procedures.

Researchers will compare 3 groups to see if orally administered probiotics based on L. rhamnosus and L. plantarum may help in the management of clinical status and salivary pH levels.

Conditions

  • Tooth Decay
  • Intellectual Disability
  • Caries,Dental

Interventions

OTHER

Test Group

Subjects will receive orally administred probiotics based on L. plantarum and L. rhamnosus for 90 days

OTHER

Positive Control

Subjects will receive orally administred probiotics based on placebo 90 days

OTHER

Negative Control

Subjects will receive esclusively instruction to perform oral hygiene procedures properly.

Sponsors & Collaborators

  • G. d'Annunzio University

    lead OTHER

Principal Investigators

  • Marco Dolci, MD DDS PHD · University G. d'Annunzio of Chieti

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-03-01
Completion
2024-05-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06063239 on ClinicalTrials.gov