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

NCT04580355 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-05-26

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • University of Campinas, Brazil

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-31
Primary Completion
2022-07-31
Completion
2022-10-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04580355 on ClinicalTrials.gov