Periodontal Diseases Clinical Trial
Official title:
Impact of Non-surgical Periodontal Therapy With or Without Antibiotics on Oral and Gut Microbiome in Patients With Stage III/IV and Grade C Periodontitis
Verified date | May 2021 |
Source | University of Campinas, Brazil |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Periodontitis is an inflammatory disease characterized by a dysbiotic microbiome which can lead to bone destruction and tooth loss. Several studies had been reported the association to periodontal disease with systemic conditions and this relation suggests and axis that links oral and gut microbiome. In order to clarify the impact of periodontal condition on gut microbiome, we aim to evaluate the clinical, immunological parameters and the microbiological condition by sequencing of subgingival biofilm and stool samples both before and after non-surgical periodontal treatment with and without antibiotics as adjunct.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | October 2022 |
Est. primary completion date | July 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - Diagnosis of Stage III/IV and grade C Periodontitis - Presence of at least 20 teeth - Good general health Exclusion Criteria: - Pregnant or lactating - Were suffering from any other systemic diseases (e.g., cardiovascular, diabetes) - Received antimicrobials in the previous 6 months - Received a course of periodontal treatment within the last 6 months - Were taking long-term anti-inflammatory drugs - Smoking habits |
Country | Name | City | State |
---|---|---|---|
Brazil | University of Campinas, UNICAMP | Piracicaba | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Campinas, Brazil |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the oral-gut axis microbiome at 3 months | Concentration of bacteria in the subgingival biofilm and stool samples | Baseline and 90 days | |
Secondary | Change of biofilm gene expression on oral microbiome at 3 months | RNA-seq of 3 samples FMUD+AM group and validation by quantitative polymerase chain reaction | Baseline and 90 days | |
Secondary | Change of the baseline inflammatory markers levels in gingival crevicular fluid (pg/uL) and stool samples | Concentration of cytokines and biomarkers in gingival crevicular fluid and in stool samples | Baseline and 90 days | |
Secondary | Change of the baseline relative clinical attachment level at 3 months | Distance from the bottom of the pocket to the stent margin. | Baseline, 30 days and 90 days |
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