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How probiotics affect the balance of bacteria in the mouth and gut of patients with Periodontitis

Microbiological modulation of the oral–gut axis after treatment with or without the systemic use of probiotics in patients with Periodontitis: a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-9j9wdbj
Enrollment
40
Registered
2026-07-08
Start date
2026-05-20
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis Inflammation

Interventions

This is a planned, controlled, two-arm clinical trial with a parallel-group design and a single-blind approach regarding the researcher performing data collection (masking). Participants (n=40) will b

Sponsors

Universidade de São Paulo
Lead Sponsor
Universidade de São Paulo
Collaborator

Eligibility

Age
30 Years to No maximum

Inclusion criteria

Inclusion criteria: Systemically healthy individuals; aged 30 years or older; both sexes; with at least 15 teeth present; 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; excluding third molars and teeth indicated for extraction; 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

Exclusion criteria

Exclusion criteria: Completely edentulous individuals; 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; use of 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.

Design outcomes

Primary

MeasureTime frame
It is expected to identify changes in periodontal parameters (full periodontal charting) by comparing the test and control groups 90 days after the completion of scaling and root planing, and the influence of probiotic use on the assessed parameters.

Secondary

MeasureTime frame
It is expected to observe an improvement in the immunoinflammatory profile of participants through the quantification of inflammatory and immunological biomarkers in biological samples from gingival crevicular fluid, using immunoenzymatic assays (Luminex), including pro- and anti-inflammatory cytokines (IL-6, TNF-a, IFN-?, IL-10, IL-1ß, IL-8), aiming to analyze the influence of periodontal therapy associated with probiotic use on these markers.

Countries

BR

Contacts

Public ContactMichel Messora

Faculdade de Odontologia de Ribeirão Preto - Universidade de São Paulo

m.messora@forp.usp.br+55-16-98271-3162

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Aug 10, 2026