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 | Completed Phase 1

• 1 other identifier: 98007426.0.0000.5419
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Periodontal Diseases; Gastrointestinal Microbiome; Probiotics; Bifidobacterium animalis; Periodontitis

Outcome Measures

Primary Outcomes (3)

• Change in clinical periodontal parameters - Plaque index (PI)

  Changes in clinical periodontal parameters including plaque index (PI) will be compared between the probiotic and placebo groups to evaluate the effect of adjunctive systemic probiotic therapy following scaling and root planing.

  Baseline and 90 days after periodontal treatment.

• Change in clinical periodontal parameters - Bleeding on Probing (BOP)

  Changes in clinical periodontal parameters including bleeding on probing (POB) will be compared between the probiotic and placebo groups to evaluate the effect of adjunctive systemic probiotic therapy following scaling and root planning.

  Baseline and 90 days after periodontal treatment.

• Change in clinical periodontal parameters - Clinical Attachment Level (CAL)

  Changes in clinical periodontal parameters including Clinical Attachment Level (CAL) will be compared between the probiotic and placebo groups to evaluate the effect of adjunctive systemic probiotic therapy following scaling and root planning.

  Baseline and 90 days after periodontal treatment.

Secondary Outcomes (1)

• Change in immunoinflammatory biomarkers in gingival crevicular fluid

  Baseline and 90 days after periodontal treatment.

Study Arms (2)

Controle

PLACEBO COMPARATOR

The control group, which will receive scaling and root planing only, without probiotics.

Dietary Supplement: Probiotics Bifidobacterium animalis subsp. lactis HN019

Probiotics

EXPERIMENTAL

The probiotic group will receive probiotic supplementation as an adjunctive therapy to scaling and root planing.

Dietary Supplement: Probiotics Bifidobacterium animalis subsp. lactis HN019

Interventions

Probiotics Bifidobacterium animalis subsp. lactis HN019 DIETARY_SUPPLEMENT

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.

Controle; Probiotics

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy individuals;
• Age of 30 years or older;
• Both genders;
• At least 15 teeth, excluding third molars and teeth indicated for extraction
• At least 30% of the teeth presenting probing depth (PD) and clinical attachment loss (CAL) greater than or equal to 5 mm;
• Individuals diagnosed with generalized Stage III or IV, Grade B or C periodontitis;
• Presence of at least 8 teeth with at least one non-contiguous interproximal site presenting probing depth (PD) and clinical attachment level (CAL) greater than or equal to 5 mm.

You may not qualify if:

• Current smokers or former smokers who quit within the past 5 years;
• Pregnant or breastfeeding women;
• History of periodontal treatment within the previous 6 months;
• Continuous use of oral antiseptics, systemic antibiotics, corticosteroids, nonsteroidal anti-inflammatory drugs, immunosuppressive agents, estrogen, selective estrogen receptor modulators, or medications that may affect bone metabolism (such as alendronate, calcitonin, and others) within the previous 6 months;
• Presence of systemic conditions that may alter the host response to periodontal treatment (such as diabetes, human papillomavirus infection, or Down syndrome) or that require antibiotic prophylaxis before dental treatment (such as mitral valve prolapse);
• Use of probiotics within the previous 6 months.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Universidade de São Paulo

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

Related Publications (1)

• Oliveira LF, Salvador SL, Silva PH, Furlaneto FA, Figueiredo L, Casarin R, Ervolino E, Palioto DB, Souza SL, Taba M Jr, Novaes AB Jr, Messora MR. Benefits of Bifidobacterium animalis subsp. lactis Probiotic in Experimental Periodontitis. J Periodontol. 2017 Feb;88(2):197-208. doi: 10.1902/jop.2016.160217. Epub 2016 Sep 23.

  PMID: 27660886 RESULT

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Renata P Aguiar, DDS, Spec

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student

Model Details: Eligible participants will be randomly allocated to two parallel groups in a 1:1 ratio. Both groups will receive scaling and root planing as conventional periodontal treatment. In addition, the experimental group will receive one daily capsule containing the probiotic Bifidobacterium animalis subsp. lactis HN019 for 30 days, while the control group will receive a placebo capsule with the same appearance and mode of administration. Participants will be followed for 90 days to evaluate clinical, immunological, and microbiological outcomes.

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 28, 2026
• Study Start: June 25, 2026
• Primary Completion: July 15, 2026
• Study Completion: July 15, 2026
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)