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

NCT ID: NCT04580355

Last Updated: 2021-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-31

Study Completion Date

2022-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Microbial Colonization Periodontal Diseases Periodontal Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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FMUD + Placebos

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.

Group Type EXPERIMENTAL

One-Stage Full Mouth Debridement

Intervention Type PROCEDURE

Periodontal debridement

Amoxicillin Placebo

Intervention Type DRUG

Administration of Placebo on the day of treatment tid for 7 days.

Metronidazole Placebo

Intervention Type DRUG

Administration of Placebo on the day of treatment tid for 7 days.

FMUD + AM

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.

Group Type ACTIVE_COMPARATOR

One-Stage Full Mouth Debridement

Intervention Type PROCEDURE

Periodontal debridement

Amoxicillin 500mg

Intervention Type DRUG

Administration of Amoxicillin 500mg prescribed on the day of treatment tid for 7 days.

Metronidazole 400mg

Intervention Type DRUG

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

Interventions

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One-Stage Full Mouth Debridement

Periodontal debridement

Intervention Type PROCEDURE

Amoxicillin 500mg

Administration of Amoxicillin 500mg prescribed on the day of treatment tid for 7 days.

Intervention Type DRUG

Metronidazole 400mg

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

Intervention Type DRUG

Amoxicillin Placebo

Administration of Placebo on the day of treatment tid for 7 days.

Intervention Type DRUG

Metronidazole Placebo

Administration of Placebo on the day of treatment tid for 7 days.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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Renato Casarin

Professor of Periodontics in Piracicaba Dental School-FOP/UNICAMP

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Campinas, UNICAMP

Piracicaba, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Renato CV Casarin, Prof. Dr.

Role: primary

+55192106-5394

Other Identifiers

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23626219.7.0000.5418

Identifier Type: -

Identifier Source: org_study_id

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