Impact of Non-surgical Periodontal Therapy on Oral and Gut Microbiome

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Microbial Colonization, Periodontal Diseases, Periodontal Inflammation

Intervention / Treatment
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* Procedure: One-Stage Full Mouth Debridement
* Drug: Amoxicillin 500mg
* Drug: Metronidazole 400mg
* Drug: Amoxicillin Placebo
* Drug: Metronidazole Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMUD + Placebos<br>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. | Procedure: One-Stage Full Mouth Debridement<br>* Periodontal debridement<br>Drug: Amoxicillin Placebo<br>* Administration of Placebo on the day of treatment tid for 7 days.<br>Drug: Metronidazole Placebo<br>* Administration of Placebo on the day of treatment tid for 7 days.<br>|
| Active Comparator: FMUD + AM<br>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. | Procedure: One-Stage Full Mouth Debridement<br>* Periodontal debridement<br>Drug: Amoxicillin 500mg<br>* Administration of Amoxicillin 500mg prescribed on the day of treatment tid for 7 days.<br>Drug: Metronidazole 400mg<br>* Administration of Metronidazole 400mg prescribed on the day of treatment tid for 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |