Inulin Supplementation During Sanative Therapy to Further Improve Periodontal Healing

Brock University

Status: Withdrawn

Conditions: Periodontitis; Periodontal Pocket; Periodontal Diseases

Treatments: Dietary Supplement: Inulin; Dietary Supplement: Maltodextrin

Study type: Interventional

Funder types: Other

Identifiers

NCT04670133

19-202

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Inulin

Experimental group

Description:

Supplementation with inulin for 4 weeks prior to and 10 weeks after sanative therapy. 10 g daily, divided into two equal doses.

Treatment:

Dietary Supplement: Inulin

Placebo

Placebo Comparator group

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.

Treatment:

Dietary Supplement: Maltodextrin