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Microbiological Modulation Of The Oral-Gut Axis After Treatment With Or Without Systemic Use Of Probiotics In Patients With Periodontitis: A Randomized Controlled Clinical Study.

NCT07792902 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-28

No results posted yet for this study

Summary

This study aims to evaluate whether the oral administration of probiotics, in combination with conventional periodontal treatment (deep cleaning of the tooth root surfaces), can improve oral health and influence the relationship between oral and gut bacteria in individuals with periodontitis.

The study will include adults aged 30 years or older diagnosed with advanced periodontitis and receiving treatment at the School of Dentistry of Ribeirão Preto, University of São Paulo (FORP/USP). Individuals with systemic diseases that may interfere with the study outcomes, pregnant or breastfeeding women, smokers, recent former smokers, or individuals who have used antibiotics, probiotics, or certain medications within the previous six months will not be eligible to participate.

Participants will be randomly assigned to two groups: one group will receive conventional periodontal treatment alone, while the other will receive the same treatment combined with probiotic supplementation. Before and after treatment, periodontal health will be assessed, including the presence of dental plaque, bleeding, periodontal pocket depth, and clinical attachment levels. Inflammatory substances present in gingival fluid will also be analyzed to evaluate the response to treatment.

The findings of this study are expected to help clarify whether probiotics used as an adjunct to periodontal treatment can reduce inflammation and promote a more balanced relationship between oral and gut microorganisms, thereby contributing to improved periodontal health.

Conditions

  • Periodontitis Stage IV
  • Periodontitis

Interventions

DIETARY_SUPPLEMENT

Probiotics Bifidobacterium animalis subsp. lactis HN019

The probiotic group will receive a dietary supplement manufactured by Aché Pharmaceuticals containing the strain Bifidobacterium animalis subsp. lactis HN019, while the control group will receive a placebo.

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Renata P Aguiar, DDS, Spec · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-25
Primary Completion
2026-07-15
Completion
2026-07-15

Countries

  • Brazil

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 NCT07792902 on ClinicalTrials.gov