Periodontal Therapy on the Gut Microbiome of Inflammatory Bowel Disease
Primary Purpose
Periodontal Diseases, IBD, Dysbiosis
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Full mouth scaling and root planing (FMSRP)
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases
Eligibility Criteria
Inclusion Criteria:
- clinical and instrumental diagnosis of ulcerative colitis or Crohn's disease
- 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
Sites / Locations
- CIR Dental SchoolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intensive periodontal treatment
Community-based periodontal care
Arm Description
Adjunctive full-mouth intensive removal of subgingival dental plaque biofilms with the use of scaling and root planing after the administration of local anesthesia.
Standard cycle of supragingival mechanical scaling and polishing.
Outcomes
Primary Outcome Measures
Changes in microbiome alpha diversity measured from stool samples at 3 months
Taxonomic and functional variation of gut bacteria after treatment
Secondary Outcome Measures
Changes in microbiome alpha diversity measured from saliva samples at 3 months
Taxonomic and functional variation of salivary bacteria after treatment
Change of the inflammatory markers levels in plasma
Concentration of cytokines and biomarkers in plasma samples
Changes in mean clinical attachment level (CAL) at 3 months
Variation in CAL after therapy assessed using a millimetre marked manual periodontal probe at 6 sites per tooth element
Changes in periodontal pocket depth (PPD) at 3 months
Variation in PPD after therapy assessed using a millimetre marked manual periodontal probe at 6 sites per tooth element
Changes in full mouth bleeding score (FMBS) at 3 months
Variation in the percentage of bleeding sites after therapy assessed by gentle probing at 6 sites per tooth element
Full Information
NCT ID
NCT04790825
First Posted
February 4, 2021
Last Updated
October 31, 2022
Sponsor
University of Turin, Italy
1. Study Identification
Unique Protocol Identification Number
NCT04790825
Brief Title
Periodontal Therapy on the Gut Microbiome of Inflammatory Bowel Disease
Official Title
Effect of Intensive or Conventional Periodontal Therapy on the Gut Microbiome and Systemic Inflammation of Patients With Inflammatory Bowel Disease: a Single-blinded Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2021 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
May 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Turin, Italy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Periodontitis and inflammatory bowel disease have been associated by meta-epidemiologic evidence, although their mechanistic connection needs to be further explored. Oral-gut axis is implicated in the pathogenesis of several chronic inflammatory conditions, but to date no studies have evaluated the impact of periodontal treatment on gut ecology. Thus, the present randomised clinical trial is aimed at investigating the effect of intensive or conventional periodontal therapy on the gut microbiome and parameters of systemic inflammation of patients diagnosed with inflammatory bowel disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, IBD, Dysbiosis, Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intensive periodontal treatment
Arm Type
Experimental
Arm Description
Adjunctive full-mouth intensive removal of subgingival dental plaque biofilms with the use of scaling and root planing after the administration of local anesthesia.
Arm Title
Community-based periodontal care
Arm Type
Active Comparator
Arm Description
Standard cycle of supragingival mechanical scaling and polishing.
Intervention Type
Procedure
Intervention Name(s)
Full mouth scaling and root planing (FMSRP)
Intervention Description
Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets completed within 48 hours
Primary Outcome Measure Information:
Title
Changes in microbiome alpha diversity measured from stool samples at 3 months
Description
Taxonomic and functional variation of gut bacteria after treatment
Time Frame
Baseline and 90 days
Secondary Outcome Measure Information:
Title
Changes in microbiome alpha diversity measured from saliva samples at 3 months
Description
Taxonomic and functional variation of salivary bacteria after treatment
Time Frame
Baseline and 90 days
Title
Change of the inflammatory markers levels in plasma
Description
Concentration of cytokines and biomarkers in plasma samples
Time Frame
Baseline and 90 days
Title
Changes in mean clinical attachment level (CAL) at 3 months
Description
Variation in CAL after therapy assessed using a millimetre marked manual periodontal probe at 6 sites per tooth element
Time Frame
Baseline and 90 days
Title
Changes in periodontal pocket depth (PPD) at 3 months
Description
Variation in PPD after therapy assessed using a millimetre marked manual periodontal probe at 6 sites per tooth element
Time Frame
Baseline and 90 days
Title
Changes in full mouth bleeding score (FMBS) at 3 months
Description
Variation in the percentage of bleeding sites after therapy assessed by gentle probing at 6 sites per tooth element
Time Frame
Baseline and 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical and instrumental diagnosis of ulcerative colitis or Crohn's disease
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
Facility Information:
Facility Name
CIR Dental School
City
Turin
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Aimetti, Prof.
Phone
+39116331541
Email
mario.aimetti@unito.it
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Periodontal Therapy on the Gut Microbiome of Inflammatory Bowel Disease
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