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

NCT04580355 Phase 4 UNKNOWN

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.

Details

Lead sponsor	University of Campinas, Brazil
Phase	Phase 4
Status	UNKNOWN
Enrolment	30
Start date	2021-07
Completion	2022-10

Conditions

• Microbial Colonization
• Periodontal Diseases
• Periodontal Inflammation

Interventions

• One-Stage Full Mouth Debridement
• Amoxicillin 500mg
• Metronidazole 400mg
• Amoxicillin Placebo
• Metronidazole Placebo

Primary outcomes

• Change in the oral-gut axis microbiome at 3 months — Baseline and 90 days
  Concentration of bacteria in the subgingival biofilm and stool samples

Countries

Brazil