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

NCT04580355 | Unknown Phase 4

• 1 other identifier: 23626219.7.0000.5418
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbial Colonization; Periodontal Diseases; Periodontal Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Change of the baseline relative clinical attachment level at 3 months

  Baseline, 30 days and 90 days

Study Arms (2)

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.

Procedure: One-Stage Full Mouth Debridement; Drug: Amoxicillin Placebo; Drug: Metronidazole Placebo

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.

Procedure: One-Stage Full Mouth Debridement; Drug: Amoxicillin 500mg; Drug: Metronidazole 400mg

Interventions

One-Stage Full Mouth Debridement PROCEDURE

Periodontal debridement

FMUD + AM; FMUD + Placebos

Amoxicillin 500mg DRUG

Administration of Amoxicillin 500mg prescribed on the day of treatment tid for 7 days.

FMUD + AM

Metronidazole 400mg DRUG

Administration of Metronidazole 400mg prescribed on the day of treatment tid for 7 days.

FMUD + AM

Amoxicillin Placebo DRUG

Administration of Placebo on the day of treatment tid for 7 days.

FMUD + Placebos

Metronidazole Placebo DRUG

Administration of Placebo on the day of treatment tid for 7 days.

FMUD + Placebos

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of Stage III/IV and grade C Periodontitis
• Presence of at least 20 teeth
• Good general health

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

University of Campinas, UNICAMP

Piracicaba, São Paulo, 13414-903, Brazil

RECRUITING

MeSH Terms

Conditions

Communicable Diseases; Periodontal Diseases

Interventions

Amoxicillin; Metronidazole

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Periodontics in Piracicaba Dental School-FOP/UNICAMP

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 8, 2020
• Study Start: July 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: October 1, 2022
• Last Updated: May 26, 2021

Record last verified: 2021-05

Locations

BR (1)