Inulin Supplementation During Sanative Therapy to Further Improve Periodontal Healing

NCT04670133 | Withdrawn

• 1 other identifier: 19-202
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontitis; Periodontal Diseases; Periodontal Pocket

Keywords

Sanative therapy; Scaling and root planing

Outcome Measures

Primary Outcomes (4)

• Probing depth

  This is a routine clinical measure of periodontal health (measured in mm)

  At pre-sanative therapy

• 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)

• 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

• 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 Outcomes (12)

• Salivary markers of inflammation

  At pre-sanative therapy

• Salivary markers of inflammation

  At sanative therapy (6 weeks after pre-sanative appointment)

• Salivary markers of inflammation

  At post-sanative therapy (10 weeks after sanative therapy is completed)

• Periodontal-Associated Pathogens

  At pre-sanative therapy

• Periodontal-Associated Pathogens

  At sanative therapy (6 weeks after pre-sanative appointment)

Study Arms (2)

Inulin

EXPERIMENTAL

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

Dietary Supplement: Inulin

Placebo

PLACEBO COMPARATOR

Supplementation with maltodextrin (as placebo) for 4 weeks prior to and 10 weeks after sanative therapy. 10 g daily, divided into two equal doses.

Dietary Supplement: Maltodextrin

Interventions

Inulin DIETARY_SUPPLEMENT

Supplementation with a prebiotic, specifically inulin.

Inulin

Maltodextrin DIETARY_SUPPLEMENT

Supplementation with maltodextrin (placebo)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brock University: lead
• Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery: collaborator

Related Publications (1)

• 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.

  PMID: 34376241 DERIVED

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases; Periodontal Pocket

Interventions

Inulin; maltodextrin

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Wendy E Ward, PhD

  Brock University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The intervention packages will be labelled with a unique code and there will be enough packages to account for the required number of participants. A member of the research team, not involved in providing the treatment, will be responsible for the randomization and labeling of the intervention packages, as well as creating a master list by matching the unique code to the treatment arm. The patient and care provider will be masked to the treatment arm.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 17, 2020
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 18, 2024

Record last verified: 2024-01