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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Supplementation with a prebiotic, specifically inulin.
Supplementation with maltodextrin (placebo)
Probing depth
This is a routine clinical measure of periodontal health (measured in mm)
Time frame: At pre-sanative therapy
Probing depth
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)
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
Time frame: 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
Time frame: At post-sanative therapy (10 weeks after sanative therapy is completed)
Salivary markers of inflammation
Levels of interleukin (IL)-1beta, IL-6, C-reactive protein (CRP), Matrix metalloproteinase-8 will be measured.
Time frame: 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.
Time frame: 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.
Time frame: At post-sanative therapy (10 weeks after sanative therapy is completed)
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Periodontal-Associated Pathogens
Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola will be measured by quantitative polymerase chain reaction (PCR).
Time frame: At pre-sanative therapy
Periodontal-Associated Pathogens
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)
Periodontal-Associated Pathogens
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: At post-sanative therapy (10 weeks after sanative therapy is completed)
Body Mass Index
Body weight and height will be measured to calculate BMI
Time frame: At pre-sanative therapy
Body Mass Index
Body weight and height will be measured to calculate BMI
Time frame: At sanative therapy (6 weeks after pre-sanative appointment)
Body Mass Index
Body weight and height will be measured to calculate BMI
Time frame: At post-sanative therapy (10 weeks after sanative therapy is completed)