Inulin Supplementation During Sanative Therapy to Further Improve Periodontal Healing
- Conditions
- PeriodontitisPeriodontal PocketPeriodontal Diseases
- Interventions
- Dietary Supplement: InulinDietary Supplement: Maltodextrin
- Registration Number
- NCT04670133
- Lead Sponsor
- Brock University
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inulin Inulin Supplementation with inulin for 4 weeks prior to and 10 weeks after sanative therapy. 10 g daily, divided into two equal doses. Placebo Maltodextrin Supplementation with maltodextrin (as placebo) for 4 weeks prior to and 10 weeks after sanative therapy. 10 g daily, divided into two equal doses.
- Primary Outcome Measures
Name Time Method Probing depth At post-sanative therapy (10 weeks after sanative therapy is completed) This is a routine clinical measure of periodontal health (measured in mm)
Bleeding on probing (BOP) 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
- Secondary Outcome Measures
Name Time Method Periodontal-Associated Pathogens 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.
Salivary markers of inflammation 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.
Body Mass Index At post-sanative therapy (10 weeks after sanative therapy is completed) Body weight and height will be measured to calculate BMI
Dietary assessment 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.