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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontal Diseases; Microbial Colonization; Periodontal Inflammation
• Intervention / Treatment: Procedure: One-Stage Full Mouth Debridement; Drug: Amoxicillin Placebo; Drug: Metronidazole Placebo; Drug: Amoxicillin 500mg; Drug: Metronidazole 400mg

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Piracicaba, Sao Paulo, Brazil, 13414-903
      • Recruiting
      • University of Campinas, UNICAMP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: One-Stage Full Mouth Debridement; Periodontal debridement; Drug: Amoxicillin Placebo; Administration of Placebo on the day of treatment tid for 7 days.; Drug: Metronidazole Placebo; Administration of Placebo on the day of treatment tid for 7 days.
ACTIVE_COMPARATOR: 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.	Procedure: One-Stage Full Mouth Debridement; Periodontal debridement; Drug: Amoxicillin 500mg; Administration of Amoxicillin 500mg prescribed on the day of treatment tid for 7 days.; Drug: Metronidazole 400mg; Administration of Metronidazole 400mg prescribed on the day of treatment tid for 7 days.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Campinas, Brazil

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2021
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (ACTUAL): October 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 26, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Stomatognathic Diseases; Mouth Diseases; Inflammation; Infections; Communicable Diseases; Periodontal Diseases; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole; Amoxicillin
• Other Study ID Numbers: 23626219.7.0000.5418

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No