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

Primary Purpose

Microbial Colonization, Periodontal Diseases, Periodontal Inflammation

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
One-Stage Full Mouth Debridement
Amoxicillin 500mg
Metronidazole 400mg
Amoxicillin Placebo
Metronidazole Placebo
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Microbial Colonization

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Campinas, UNICAMPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FMUD + Placebos

FMUD + AM

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in the oral-gut axis microbiome at 3 months
Concentration of bacteria in the subgingival biofilm and stool samples

Secondary Outcome Measures

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
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
Change of the baseline relative clinical attachment level at 3 months
Distance from the bottom of the pocket to the stent margin.

Full Information

First Posted
October 1, 2020
Last Updated
May 25, 2021
Sponsor
University of Campinas, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT04580355
Brief Title
Impact of Non-surgical Periodontal Therapy on Oral and Gut Microbiome
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 2021 (Anticipated)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization, Periodontal Diseases, Periodontal Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FMUD + Placebos
Arm Type
Experimental
Arm Description
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.
Arm Title
FMUD + AM
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
One-Stage Full Mouth Debridement
Intervention Description
Periodontal debridement
Intervention Type
Drug
Intervention Name(s)
Amoxicillin 500mg
Intervention Description
Administration of Amoxicillin 500mg prescribed on the day of treatment tid for 7 days.
Intervention Type
Drug
Intervention Name(s)
Metronidazole 400mg
Intervention Description
Administration of Metronidazole 400mg prescribed on the day of treatment tid for 7 days.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin Placebo
Intervention Description
Administration of Placebo on the day of treatment tid for 7 days.
Intervention Type
Drug
Intervention Name(s)
Metronidazole Placebo
Intervention Description
Administration of Placebo on the day of treatment tid for 7 days.
Primary Outcome Measure Information:
Title
Change in the oral-gut axis microbiome at 3 months
Description
Concentration of bacteria in the subgingival biofilm and stool samples
Time Frame
Baseline and 90 days
Secondary Outcome Measure Information:
Title
Change of biofilm gene expression on oral microbiome at 3 months
Description
RNA-seq of 3 samples FMUD+AM group and validation by quantitative polymerase chain reaction
Time Frame
Baseline and 90 days
Title
Change of the baseline inflammatory markers levels in gingival crevicular fluid (pg/uL) and stool samples
Description
Concentration of cytokines and biomarkers in gingival crevicular fluid and in stool samples
Time Frame
Baseline and 90 days
Title
Change of the baseline relative clinical attachment level at 3 months
Description
Distance from the bottom of the pocket to the stent margin.
Time Frame
Baseline, 30 days and 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Campinas, UNICAMP
City
Piracicaba
State/Province
Sao Paulo
ZIP/Postal Code
13414-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renato CV Casarin, Prof. Dr.
Phone
+55192106-5394
Email
casarinrcv@yahoo.com.br

12. IPD Sharing Statement

Learn more about this trial

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

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