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Inulin Supplementation During Sanative Therapy to Further Improve Periodontal Healing

Primary Purpose

Periodontitis, Periodontal Diseases, Periodontal Pocket

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inulin
Maltodextrin
Sponsored by
Brock University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Periodontitis focused on measuring Sanative therapy, Scaling and root planing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Both males and females age 19 years or older who are undergoing sanative therapy for moderate to severe chronic periodontitis are eligible
  • Provided informed, written consent

Exclusion Criteria:

  • Patients with severe periodontal disease that requires antibiotics with ST as part of their treatment
  • Hemoglobin A1c levels greater than 8% in the previous 3 months
  • Chronic GI conditions and/or infections (e.g. colon cancer, crohn's disease, inflammatory bowel disease, celiac disease and ulcerative colitis)
  • Current or previous use of antibiotics for management of non-periodontal conditions within the past 3 month
  • Current use of laxatives, prebiotics, probiotics and/or fibre supplements
  • Smokers and/or cannabis users
  • Pregnant or breast-feeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Inulin

    Placebo

    Arm Description

    Supplementation with inulin for 4 weeks prior to and 10 weeks after sanative therapy. 10 g daily, divided into two equal doses.

    Supplementation with maltodextrin (as placebo) for 4 weeks prior to and 10 weeks after sanative therapy. 10 g daily, divided into two equal doses.

    Outcomes

    Primary Outcome Measures

    Probing depth
    This is a routine clinical measure of periodontal health (measured in mm)
    Probing depth
    This is a routine clinical measure of periodontal health (measured in mm)
    Bleeding on probing (BOP)
    This is a clinical measure of inflammation and represented as the percentage to bleeding sites that are measured at 6 sites per tooth
    Bleeding on probing (BOP)
    This is a clinical measure of inflammation and represented as the percentage to bleeding sites that are measured at 6 sites per tooth

    Secondary Outcome Measures

    Salivary markers of inflammation
    Levels of interleukin (IL)-1beta, IL-6, C-reactive protein (CRP), Matrix metalloproteinase-8 will be measured.
    Salivary markers of inflammation
    Levels of interleukin (IL)-1beta, IL-6, C-reactive protein (CRP), Matrix metalloproteinase-8 will be measured.
    Salivary markers of inflammation
    Levels of interleukin (IL)-1beta, IL-6, C-reactive protein (CRP), Matrix metalloproteinase-8 will be measured.
    Periodontal-Associated Pathogens
    Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola will be measured by quantitative polymerase chain reaction (PCR).
    Periodontal-Associated Pathogens
    Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola will be measured by quantitative PCR.
    Periodontal-Associated Pathogens
    Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola will be measured by quantitative PCR.
    Dietary assessment
    Intake of energy, carbohydrate, fat and protein will be measured with the automated self-administered dietary intake (ASA-24) questionnaire. This is an online food recall that patients will complete three times for each visit, reporting on their dietary intake from the last 24 hours.
    Dietary assessment
    Intake of energy, carbohydrate, fat and protein will be measured with the automated self-administered dietary intake (ASA-24) questionnaire. This is an online food recall that patients will complete three times for each visit, reporting on their dietary intake from the last 24 hours.
    Dietary assessment
    Intake of energy, carbohydrate, fat and protein will be measured with the automated self-administered dietary intake (ASA-24) questionnaire. This is an online food recall that patients will complete three times for each visit, reporting on their dietary intake from the last 24 hours.
    Body Mass Index
    Body weight and height will be measured to calculate BMI
    Body Mass Index
    Body weight and height will be measured to calculate BMI
    Body Mass Index
    Body weight and height will be measured to calculate BMI

    Full Information

    First Posted
    December 2, 2020
    Last Updated
    April 2, 2023
    Sponsor
    Brock University
    Collaborators
    Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04670133
    Brief Title
    Inulin Supplementation During Sanative Therapy to Further Improve Periodontal Healing
    Official Title
    Intervention With Inulin to Further Support Effectiveness of Sanative Therapy: Study Protocol for a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brock University
    Collaborators
    Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery

    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
    The aim of this study is to investigate the effectiveness of daily supplementation with inulin before, during and after sanative therapy (ST), on clinical outcomes of periodontal disease. The study design will allow the investigators to conclude if supplementation with inulin can favourably modulate oral microbiota prior to ST and can result in better periodontal health after ST.
    Detailed Description
    Periodontal disease is a chronic state of inflammation that can destroy the supporting tissues around the teeth, leading to a loss of connective tissue and the periodontal ligament, the resorption of alveolar bone and eventual tooth loss. Periodontal disease can also induce dysbiosis in the gut microbiome and contribute to low grade systemic inflammation. Prebiotic fibres such as inulin can selectively alter the intestinal microbiota to bring back a state of homeostasis by improving gut barrier functions and preventing inflammation. Through this mechanism, supplementation with inulin may be able to indirectly benefit periodontal health. The primary objective of this trial to determine if inulin supplementation, provided pre-sanative therapy (ST) through the healing phase (post-ST) is more effective than the placebo at improving clinical outcomes of periodontal health: decreasing both the number of sites with probing depths greater than or equal to 4 mm and increasing the absence of bleeding on probing (BOP). Secondary objectives include determining the effects of inulin supplementation pre- and post-ST on salivary markers of inflammation and periodontal-associated pathogens.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis, Periodontal Diseases, Periodontal Pocket
    Keywords
    Sanative therapy, Scaling and root planing

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Subjects will be randomized to receive one of the two treatments. They will be required to take one sachet per day (half in the morning; half in the evening) of the assigned intervention beginning 4 weeks before their scheduled sanative therapy appointment and remain on the intervention until 10 weeks after their sanative therapy appointment.
    Masking
    ParticipantCare Provider
    Masking Description
    The intervention packages will be labelled with a unique code and there will be enough packages to account for the required number of participants. A member of the research team, not involved in providing the treatment, will be responsible for the randomization and labeling of the intervention packages, as well as creating a master list by matching the unique code to the treatment arm. The patient and care provider will be masked to the treatment arm.
    Allocation
    Randomized
    Enrollment
    170 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Inulin
    Arm Type
    Experimental
    Arm Description
    Supplementation with inulin for 4 weeks prior to and 10 weeks after sanative therapy. 10 g daily, divided into two equal doses.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Supplementation with maltodextrin (as placebo) for 4 weeks prior to and 10 weeks after sanative therapy. 10 g daily, divided into two equal doses.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Inulin
    Intervention Description
    Supplementation with a prebiotic, specifically inulin.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Maltodextrin
    Intervention Description
    Supplementation with maltodextrin (placebo)
    Primary Outcome Measure Information:
    Title
    Probing depth
    Description
    This is a routine clinical measure of periodontal health (measured in mm)
    Time Frame
    At pre-sanative therapy
    Title
    Probing depth
    Description
    This is a routine clinical measure of periodontal health (measured in mm)
    Time Frame
    At post-sanative therapy (10 weeks after sanative therapy is completed)
    Title
    Bleeding on probing (BOP)
    Description
    This is a clinical measure of inflammation and represented as the percentage to bleeding sites that are measured at 6 sites per tooth
    Time Frame
    At pre-sanative therapy
    Title
    Bleeding on probing (BOP)
    Description
    This is a clinical measure of inflammation and represented as the percentage to bleeding sites that are measured at 6 sites per tooth
    Time Frame
    At post-sanative therapy (10 weeks after sanative therapy is completed)
    Secondary Outcome Measure Information:
    Title
    Salivary markers of inflammation
    Description
    Levels of interleukin (IL)-1beta, IL-6, C-reactive protein (CRP), Matrix metalloproteinase-8 will be measured.
    Time Frame
    At pre-sanative therapy
    Title
    Salivary markers of inflammation
    Description
    Levels of interleukin (IL)-1beta, IL-6, C-reactive protein (CRP), Matrix metalloproteinase-8 will be measured.
    Time Frame
    At sanative therapy (6 weeks after pre-sanative appointment)
    Title
    Salivary markers of inflammation
    Description
    Levels of interleukin (IL)-1beta, IL-6, C-reactive protein (CRP), Matrix metalloproteinase-8 will be measured.
    Time Frame
    At post-sanative therapy (10 weeks after sanative therapy is completed)
    Title
    Periodontal-Associated Pathogens
    Description
    Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola will be measured by quantitative polymerase chain reaction (PCR).
    Time Frame
    At pre-sanative therapy
    Title
    Periodontal-Associated Pathogens
    Description
    Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola will be measured by quantitative PCR.
    Time Frame
    At sanative therapy (6 weeks after pre-sanative appointment)
    Title
    Periodontal-Associated Pathogens
    Description
    Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola will be measured by quantitative PCR.
    Time Frame
    At post-sanative therapy (10 weeks after sanative therapy is completed)
    Title
    Dietary assessment
    Description
    Intake of energy, carbohydrate, fat and protein will be measured with the automated self-administered dietary intake (ASA-24) questionnaire. This is an online food recall that patients will complete three times for each visit, reporting on their dietary intake from the last 24 hours.
    Time Frame
    At pre-sanative therapy
    Title
    Dietary assessment
    Description
    Intake of energy, carbohydrate, fat and protein will be measured with the automated self-administered dietary intake (ASA-24) questionnaire. This is an online food recall that patients will complete three times for each visit, reporting on their dietary intake from the last 24 hours.
    Time Frame
    At sanative therapy (6 weeks after pre-sanative appointment)
    Title
    Dietary assessment
    Description
    Intake of energy, carbohydrate, fat and protein will be measured with the automated self-administered dietary intake (ASA-24) questionnaire. This is an online food recall that patients will complete three times for each visit, reporting on their dietary intake from the last 24 hours.
    Time Frame
    At post-sanative therapy (10 weeks after sanative therapy is completed)
    Title
    Body Mass Index
    Description
    Body weight and height will be measured to calculate BMI
    Time Frame
    At pre-sanative therapy
    Title
    Body Mass Index
    Description
    Body weight and height will be measured to calculate BMI
    Time Frame
    At sanative therapy (6 weeks after pre-sanative appointment)
    Title
    Body Mass Index
    Description
    Body weight and height will be measured to calculate BMI
    Time Frame
    At post-sanative therapy (10 weeks after sanative therapy is completed)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Both males and females age 19 years or older who are undergoing sanative therapy for moderate to severe chronic periodontitis are eligible Provided informed, written consent Exclusion Criteria: Patients with severe periodontal disease that requires antibiotics with ST as part of their treatment Hemoglobin A1c levels greater than 8% in the previous 3 months Chronic GI conditions and/or infections (e.g. colon cancer, crohn's disease, inflammatory bowel disease, celiac disease and ulcerative colitis) Current or previous use of antibiotics for management of non-periodontal conditions within the past 3 month Current use of laxatives, prebiotics, probiotics and/or fibre supplements Smokers and/or cannabis users Pregnant or breast-feeding
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wendy E Ward, PhD
    Phone
    905 688 5550
    Ext
    3024
    Email
    wward@brocku.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Peter C Fritz, DDS
    Phone
    905 892 0800
    Email
    peter.fritz@utoronto.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wendy E Ward, PhD
    Organizational Affiliation
    Brock University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34376241
    Citation
    Zanatta CAR, Fritz PC, Comelli EM, Ward WE. Intervention with inulin prior to and during sanative therapy to further support periodontal health: study protocol for a randomized controlled trial. Trials. 2021 Aug 10;22(1):527. doi: 10.1186/s13063-021-05504-1.
    Results Reference
    derived

    Learn more about this trial

    Inulin Supplementation During Sanative Therapy to Further Improve Periodontal Healing

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