Microbial Colonization, Periodontal Diseases, Periodontal Inflammation
Conditions
Brief summary
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.
Interventions
PROCEDUREOne-Stage Full Mouth Debridement
Periodontal debridement
Administration of Amoxicillin 500mg prescribed on the day of treatment tid for 7 days.
Administration of Metronidazole 400mg prescribed on the day of treatment tid for 7 days.
Administration of Placebo on the day of treatment tid for 7 days.
Administration of Placebo on the day of treatment tid for 7 days.
Sponsors
University of Campinas, Brazil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the oral-gut axis microbiome at 3 months | Baseline and 90 days | Concentration of bacteria in the subgingival biofilm and stool samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of biofilm gene expression on oral microbiome at 3 months | Baseline and 90 days | RNA-seq of 3 samples FMUD+AM group and validation by quantitative polymerase chain reaction |
| Change of the baseline inflammatory markers levels in gingival crevicular fluid (pg/uL) and stool samples | Baseline and 90 days | Concentration of cytokines and biomarkers in gingival crevicular fluid and in stool samples |
| Change of the baseline relative clinical attachment level at 3 months | Baseline, 30 days and 90 days | Distance from the bottom of the pocket to the stent margin. |
Countries
Brazil
Outcome results
None listed