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

Periodontal Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04580355
• Other study ID #: 23626219.7.0000.5418
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Inflammation
• Microbial Colonization
• Periodontal Diseases
• Periodontal Inflammation

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