Impact of Non-surgical Periodontal Therapy on Oral and Gut Microbiome
- Conditions
- Periodontal InflammationPeriodontal DiseasesMicrobial Colonization
- Interventions
- Procedure: One-Stage Full Mouth Debridement
- Registration Number
- NCT04580355
- Lead Sponsor
- University of Campinas, Brazil
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Diagnosis of Stage III/IV and grade C Periodontitis
- Presence of at least 20 teeth
- Good general health
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FMUD + AM Metronidazole 400mg 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. FMUD + Placebos Metronidazole Placebo 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 One-Stage Full Mouth Debridement 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. FMUD + AM Amoxicillin 500mg 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. FMUD + Placebos One-Stage Full Mouth Debridement 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 + Placebos Amoxicillin Placebo 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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
Trial Locations
- Locations (1)
University of Campinas, UNICAMP
🇧🇷Piracicaba, Sao Paulo, Brazil