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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMUD + Placebos | Experimental | One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus placebo administration prescribed on the day of treatment, every 8 hours for 7 days. |
|
| FMUD + AM | Active Comparator | One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus 500 mg Amoxicillin and 250 mg Metronidazole (AM) prescribed on the day of treatment, every 8 hours for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One-Stage Full Mouth Debridement | Procedure | Periodontal debridement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the oral-gut axis microbiome at 3 months | Concentration of bacteria in the subgingival biofilm and stool samples | Baseline and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change of the baseline inflammatory markers levels in gingival crevicular fluid (pg/uL) and stool samples |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Campinas, UNICAMP | Recruiting | Piracicaba | São Paulo | 13414-903 | Brazil |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Amoxicillin 500mg | Drug | Administration of Amoxicillin 500mg prescribed on the day of treatment tid for 7 days. |
|
| Metronidazole 400mg | Drug | Administration of Metronidazole 400mg prescribed on the day of treatment tid for 7 days. |
|
| Amoxicillin Placebo | Drug | Administration of Placebo on the day of treatment tid for 7 days. |
|
| Metronidazole Placebo | Drug | Administration of Placebo on the day of treatment tid for 7 days. |
|
Concentration of cytokines and biomarkers in gingival crevicular fluid and in stool samples |
| Baseline and 90 days |
| 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 |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |