Inulin Supplementation During Sanative Therapy to Further Improve Periodontal Healing

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Periodontitis, Periodontal Diseases, Periodontal Pocket

Intervention / Treatment
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* Dietary Supplement: Inulin
* Dietary Supplement: Maltodextrin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inulin<br>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<br>* Supplementation with a prebiotic, specifically inulin.<br>|
| Placebo Comparator: Placebo<br>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<br>* Supplementation with maltodextrin (placebo)<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sanative therapy, Scaling and root planing