Inulin Supplementation During Sanative Therapy to Further Improve Periodontal Healing

January 16, 2024 updated by: Wendy E. Ward, Ph.D., Brock University

Intervention With Inulin to Further Support Effectiveness of Sanative Therapy: Study Protocol for a Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Wendy E Ward, PhD
  • Phone Number: 3024 905 688 5550
  • Email: wward@brocku.ca

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Inulin
Supplementation with inulin for 4 weeks prior to and 10 weeks after sanative therapy. 10 g daily, divided into two equal doses.
Dietary supplement: Inulin
Supplementation with a prebiotic, specifically inulin.
Placebo Comparator: Placebo
Supplementation with maltodextrin (as placebo) for 4 weeks prior to and 10 weeks after sanative therapy. 10 g daily, divided into two equal doses.
Dietary supplement: Maltodextrin
Supplementation with maltodextrin (placebo)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Probing depth
Time Frame: At pre-sanative therapy
This is a routine clinical measure of periodontal health (measured in mm)
At pre-sanative therapy
Probing depth
Time Frame: At post-sanative therapy (10 weeks after sanative therapy is completed)
This is a routine clinical measure of periodontal health (measured in mm)
At post-sanative therapy (10 weeks after sanative therapy is completed)
Bleeding on probing (BOP)
Time Frame: At pre-sanative therapy
This is a clinical measure of inflammation and represented as the percentage to bleeding sites that are measured at 6 sites per tooth
At pre-sanative therapy
Bleeding on probing (BOP)
Time Frame: At post-sanative therapy (10 weeks after sanative therapy is completed)
This is a clinical measure of inflammation and represented as the percentage to bleeding sites that are measured at 6 sites per tooth
At post-sanative therapy (10 weeks after sanative therapy is completed)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Salivary markers of inflammation
Time Frame: At pre-sanative therapy
Levels of interleukin (IL)-1beta, IL-6, C-reactive protein (CRP), Matrix metalloproteinase-8 will be measured.
At pre-sanative therapy
Salivary markers of inflammation
Time Frame: At sanative therapy (6 weeks after pre-sanative appointment)
Levels of interleukin (IL)-1beta, IL-6, C-reactive protein (CRP), Matrix metalloproteinase-8 will be measured.
At sanative therapy (6 weeks after pre-sanative appointment)
Salivary markers of inflammation
Time Frame: At post-sanative therapy (10 weeks after sanative therapy is completed)
Levels of interleukin (IL)-1beta, IL-6, C-reactive protein (CRP), Matrix metalloproteinase-8 will be measured.
At post-sanative therapy (10 weeks after sanative therapy is completed)
Periodontal-Associated Pathogens
Time Frame: At pre-sanative therapy
Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola will be measured by quantitative polymerase chain reaction (PCR).
At pre-sanative therapy
Periodontal-Associated Pathogens
Time Frame: At sanative therapy (6 weeks after pre-sanative appointment)
Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola will be measured by quantitative PCR.
At sanative therapy (6 weeks after pre-sanative appointment)
Periodontal-Associated Pathogens
Time Frame: At post-sanative therapy (10 weeks after sanative therapy is completed)
Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola will be measured by quantitative PCR.
At post-sanative therapy (10 weeks after sanative therapy is completed)
Dietary assessment
Time Frame: At pre-sanative therapy
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.
At pre-sanative therapy
Dietary assessment
Time Frame: At sanative therapy (6 weeks after pre-sanative appointment)
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.
At sanative therapy (6 weeks after pre-sanative appointment)
Dietary assessment
Time Frame: At post-sanative therapy (10 weeks after sanative therapy is completed)
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.
At post-sanative therapy (10 weeks after sanative therapy is completed)
Body Mass Index
Time Frame: At pre-sanative therapy
Body weight and height will be measured to calculate BMI
At pre-sanative therapy
Body Mass Index
Time Frame: At sanative therapy (6 weeks after pre-sanative appointment)
Body weight and height will be measured to calculate BMI
At sanative therapy (6 weeks after pre-sanative appointment)
Body Mass Index
Time Frame: At post-sanative therapy (10 weeks after sanative therapy is completed)
Body weight and height will be measured to calculate BMI
At post-sanative therapy (10 weeks after sanative therapy is completed)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brock University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wendy E Ward, PhD, Brock University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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