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How the use of probiotics may help control the development of Periodontal Disease

Evaluation of the effect of a Probiotic on the progression of Periodontitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4xc37tm
Enrollment
Unknown
Registered
2025-05-08
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Periodontitis

Interventions

This is a randomized, controlled, two-arm, double-blind clinical trial. The experimental group will consist of 43 adult individuals with stage III or IV periodontitis, in the maintenance phase of peri
G07.203.300.456.500
G07.203.300.456

Sponsors

Faculdade de Odontologia da Universidade de São Paulo
Lead Sponsor
Faculdade de Odontologia da Universidade de São Paulo
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Being man or woman. Having stage III or IV periodontitis. Having received treatment for active periodontitis, including mechanical therapy with or without antibiotic therapy using amoxicillin and metronidazole, at the clinic of the School of Dentistry, University of São Paulo. Currently being in the supportive periodontal therapy phase. Being in good general health. Having at least six teeth present in the oral cavity, with at least one non-adjacent interproximal site presenting probing depth (PD) and clinical attachment level (CAL) equal to or greater than 5mm. Being over 18 years of age

Exclusion criteria

Exclusion criteria: Presenting any systemic condition that may influence the course of periodontal disease, such as diabetes, or that requires the use of systemic antibiotics. Being a smoker. Having a Body Mass Index (BMI) greater than 30 kilograms per square meter. Being pregnant or breastfeeding. Having used systemic antibiotics in the three months prior to the beginning of the study. Frequently using mouthwashes. Regularly consuming probiotic products. Being under 18 years of age

Design outcomes

Primary

MeasureTime frame
Assessing the mean reduction in probing depth (PD) at 3 months, considering all probed periodontal sites. Statistical analyses will be performed to determine the presence or absence of statistically significant differences between the groups and between the experimental time points, with the results presented in tables.

Secondary

MeasureTime frame
To evaluate the clinical parameters of mean bleeding on probing (considering all probed sites) and the mean full-mouth plaque index, obtained through completion of the periodontal chart at baseline and after three months. Statistical analyses will be performed to determine the presence or absence of statistically significant differences between the groups and between the experimental time points, with the results presented in tables. Salivary levels of pro- and anti-inflammatory cytokines, chemokines, and MMP-8 will be measured using enzyme-linked immunosorbent assay (ELISA), followed by statistical analysis to identify any significant differences between groups and time points, with the data presented in graphical format.

Countries

Brazil

Contacts

Public ContactMarcia Mayer

Faculdade de Odontologia da Universidade de São Paulo

mpamayer@icb.usp.br+55 (11) 30917211

Outcome results

None listed

Source: REBEC (via WHO ICTRP)