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

University of Campinas, Brazil

Status and phase: Unknown; Phase 4

Conditions: Microbial Colonization; Periodontal Diseases; Periodontal Inflammation

Treatments: Drug: Metronidazole Placebo; Drug: Metronidazole 400mg; Procedure: One-Stage Full Mouth Debridement; Drug: Amoxicillin Placebo; Drug: Amoxicillin 500mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04580355

23626219.7.0000.5418

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

FMUD + Placebos

Experimental group

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.

Treatment:

Drug: Amoxicillin Placebo

Drug: Metronidazole Placebo

Procedure: One-Stage Full Mouth Debridement

FMUD + AM

Active Comparator group

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.

Treatment:

Drug: Metronidazole 400mg

Procedure: One-Stage Full Mouth Debridement

Drug: Amoxicillin 500mg