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Clinical and Microbiological Aspects of Probiotics in Non-surgical Periodontal Therapy.

NCT06063226 · 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 people suffering from periodontitis stage II-III. 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 non-surgical periodontal therapy in reducing clinical periodontal indexes?
* QUESTION 2: orally administered probiotics based on the previous strains could represent a useful tool in support of non-surgical periodontal therapy in reduce the amount of periodontal pathogens in periodontal pockets?

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 hel in the reduction of periodontal indexes and of the periodontal pathogen bacteria.

Conditions

  • Periodontitis
  • Probiotics
  • Non Surgical Periodontal Therapy

Interventions

OTHER

Experimental

Orally administred probiotics with L. plantarum and L. rhamnosus

OTHER

Negative control

Only routinary oral hygiene procedures

OTHER

Positive control

Orally administred placebo without probiotics

Sponsors & Collaborators

  • Probiotical S.p.A.

    collaborator INDUSTRY

  • 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
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-03-01
Completion
2024-06-01

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 NCT06063226 on ClinicalTrials.gov