Inulin Supplementation During Sanative Therapy to Further Improve Periodontal Healing

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04670133
• Other study ID #: 19-202
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: Brock University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases
• Periodontal Pocket
• Periodontitis

Intervention

Dietary Supplement:
• Inulin
Supplementation with a prebiotic, specifically inulin.
• Maltodextrin
Supplementation with maltodextrin (placebo)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Brock University	Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing depth	This is a routine clinical measure of periodontal health (measured in mm)	At pre-sanative therapy
Primary	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)
Primary	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
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	Periodontal-Associated Pathogens	Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola will be measured by quantitative polymerase chain reaction (PCR).	At pre-sanative therapy
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	Body Mass Index	Body weight and height will be measured to calculate BMI	At pre-sanative therapy
Secondary	Body Mass Index	Body weight and height will be measured to calculate BMI	At sanative therapy (6 weeks after pre-sanative appointment)
Secondary	Body Mass Index	Body weight and height will be measured to calculate BMI	At post-sanative therapy (10 weeks after sanative therapy is completed)