Clinical trial NCT04670133: Inulin Supplementation During Sanative Therapy to Further Improve Periodontal Healing
Official title: Intervention With Inulin to Further Support Effectiveness of Sanative Therapy: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Periodontitis
Periodontal Diseases
Periodontal Pocket
Keywords: Sanative therapy
Scaling and root planing
Lead sponsor: Brock University
Sponsor class: OTHER
Collaborators: name: Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
First posted: 2020-12-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Probing depth
timeFrame: At pre-sanative therapy
measure: Probing depth
timeFrame: At post-sanative therapy (10 weeks after sanative therapy is completed)
measure: Bleeding on probing (BOP)
timeFrame: At pre-sanative therapy
measure: Bleeding on probing (BOP)
timeFrame: At post-sanative therapy (10 weeks after sanative therapy is completed)
Secondary outcomes:
measure: Salivary markers of inflammation
timeFrame: At pre-sanative therapy
measure: Salivary markers of inflammation
timeFrame: At sanative therapy (6 weeks after pre-sanative appointment)
measure: Salivary markers of inflammation
timeFrame: At post-sanative therapy (10 weeks after sanative therapy is completed)
measure: Periodontal-Associated Pathogens
timeFrame: At pre-sanative therapy
measure: Periodontal-Associated Pathogens
timeFrame: At sanative therapy (6 weeks after pre-sanative appointment)
measure: Periodontal-Associated Pathogens
timeFrame: At post-sanative therapy (10 weeks after sanative therapy is completed)
measure: Dietary assessment
timeFrame: At pre-sanative therapy
measure: Dietary assessment
timeFrame: At sanative therapy (6 weeks after pre-sanative appointment)
measure: Dietary assessment
timeFrame: At post-sanative therapy (10 weeks after sanative therapy is completed)
measure: Body Mass Index
timeFrame: At pre-sanative therapy
measure: Body Mass Index
timeFrame: At sanative therapy (6 weeks after pre-sanative appointment)
measure: Body Mass Index
timeFrame: At post-sanative therapy (10 weeks after sanative therapy is completed)
Other outcomes:
Locations:
Study officials:
affiliation: Brock University
name: Wendy E Ward, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.