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
Overview
- Phase
- Phase 4
- Intervention
- One-Stage Full Mouth Debridement
- Conditions
- Microbial Colonization
- Sponsor
- University of Campinas, Brazil
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in the oral-gut axis microbiome at 3 months
- Last Updated
- 4 years ago
Overview
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.
Investigators
Renato Casarin
Professor of Periodontics in Piracicaba Dental School-FOP/UNICAMP
University of Campinas, Brazil
Eligibility Criteria
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
Arms & Interventions
FMUD + Placebos
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.
Intervention: One-Stage Full Mouth Debridement
FMUD + Placebos
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.
Intervention: Amoxicillin Placebo
FMUD + Placebos
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.
Intervention: Metronidazole Placebo
FMUD + AM
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.
Intervention: One-Stage Full Mouth Debridement
FMUD + AM
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.
Intervention: Amoxicillin 500mg
FMUD + AM
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.
Intervention: Metronidazole 400mg
Outcomes
Primary Outcomes
Change in the oral-gut axis microbiome at 3 months
Time Frame: Baseline and 90 days
Concentration of bacteria in the subgingival biofilm and stool samples
Secondary Outcomes
- Change of the baseline relative clinical attachment level at 3 months(Baseline, 30 days and 90 days)
- Change of biofilm gene expression on oral microbiome at 3 months(Baseline and 90 days)
- Change of the baseline inflammatory markers levels in gingival crevicular fluid (pg/uL) and stool samples(Baseline and 90 days)