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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04580355
Other study ID # 23626219.7.0000.5418
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date July 2021
Est. completion date October 2022

Study information

Verified date May 2021
Source University of Campinas, Brazil
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date October 2022
Est. primary completion date July 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Brazil University of Campinas, UNICAMP Piracicaba Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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