NCT04580355

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Campinas, Brazil · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-07-01
• Completion: 2022-10-01
• First posted: 2020-10-08
• Last updated: 2021-05-26

Locations

1 site across 1 country: Brazil