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
About this trial
This is an interventional supportive care trial for Periodontitis focused on measuring Sanative therapy, Scaling and root planing
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
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
NCT ID
NCT04670133
First Posted
December 2, 2020
Last Updated
April 2, 2023
Sponsor
Brock University
Collaborators
Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
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
We'll reach out to this number within 24 hrs