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OpenTrials
Completed

NCT Number: NCT04982302

Gut Microbial Changes After Periodontal Treatment

Periodontitis is a chronic inflammatory disease of the tooth supporting structures induced by a dysbiosis in the oral and subgingival microenvironment of susceptible patients. The long-term swallowing of high doses of periodontal pathogenic microorganisms could induce a dysbiosis of the intestinal microbiota, favouring the establishment of an 'inflamed' microbiome in terms of composition and/or function. The present project is aimed at a better understanding of the etiopathogenetic correlation between periodontitis and intestinal dysbiosis, and aims to explore the hypothesis that non-surgical periodontal treatment may reduce bacterial alpha diversity in stool samples. Fifty patients affected by stage III-IV periodontitis will be recruited, and treated by means of full-mouth scaling and root planing. Salivary and stool samples, together with a complete periodontal charting and a food diary will be collected and compared at baseline and 3 months after treatment. Age, gender and BMI-matched healthy individuals will be recruited as controls.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CIR Dental School

Turin, 10126, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • periodontitis Stage III or IV
  • BMI between 20 and 29 kg/m2
  • free diet
  • presence of at least 20 teeth

Exclusion criteria

  • systemic diseases (including diabetes, thyroid, liver, or kidney diseases)
  • dietary allergies
  • use of antibiotics or probiotics during the previous 30 days
  • pregnancy or breast feeding

Treatment and study plan

Non-surgical periodontal treatment

Procedure

Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets

Primary outcomes

  1. Changes in microbiome alpha diversity measured from stool samples at 3 months

    Time frame: [Time Frame: Baseline and 90 days]

    Taxonomic and functional variation of gut bacteria after treatment

Secondary outcomes

  1. Changes in microbiome alpha diversity measured from saliva samples at 3 months

    Time frame: [Time Frame: Baseline and 90 days]

    Taxonomic and functional variation of salivary bacteria after treatment

  2. Changes in mean clinical attachment level (CAL) at 3 months

    Time frame: [Time Frame: Baseline and 90 days]

    Variation in CAL after therapy assessed using a millimetre marked manual periodontal probe at 6 sites per tooth element

  3. Changes in periodontal pocket depth (PPD) at 3 months

    Time frame: [Time Frame: Baseline and 90 days]

    Variation in PPD after therapy assessed using a millimetre marked manual periodontal probe at 6 sites per tooth element

  4. Changes in full mouth bleeding score (FMBS) at 3 months

    Time frame: [Time Frame: Baseline and 90 days]

    Variation in the percentage of bleeding sites after therapy assessed by gentle probing at 6 sites per tooth element

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Evaluation of Salivary and Intestinal Microbiological Response in Patients With Stage III-IV Periodontitis After Non-surgical Periodontal Therapy

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 29, 2021
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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