Inulin Supplementation During Sanative Therapy to Further Improve Periodontal Healing

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• Status: Withdrawn
• Conditions: Periodontitis; Periodontal Diseases; Periodontal Pocket
• Intervention / Treatment: Dietary supplement: Inulin; Dietary supplement: Maltodextrin

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: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Probing depth	This is a routine clinical measure of periodontal health (measured in mm)	At pre-sanative therapy
Probing depth	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)	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)	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

Outcome Measure	Measure Description	Time Frame
Salivary markers of inflammation	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	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	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	Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola will be measured by quantitative polymerase chain reaction (PCR).	At pre-sanative therapy
Periodontal-Associated Pathogens	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	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	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	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	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	Body weight and height will be measured to calculate BMI	At pre-sanative therapy
Body Mass Index	Body weight and height will be measured to calculate BMI	At sanative therapy (6 weeks after pre-sanative appointment)
Body Mass Index	Body weight and height will be measured to calculate BMI	At post-sanative therapy (10 weeks after sanative therapy is completed)

Collaborators and Investigators

• Sponsor: Brock University
• Collaborators: Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
• Investigators: Principal Investigator: Wendy E Ward, PhD, Brock University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 2, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Scaling and root planing; Sanative therapy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontitis; Periodontal Diseases; Periodontal Pocket
• Other Study ID 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