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Effect on Oral-cardio Health From Dietary Nitrate Loaded Functional Gum

Primary Purpose

Gingivitis, Cardiovascular Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
dietary nitrate
Placebo chewing gum
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingivitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult subjects with mild to moderate gingivitis, as defined with a MGI score of at least 2.0 Subjects must have a minimum of 20 natural teeth Subjects must able to chew gum Exclusion Criteria: Significant alveolar bone loss (>3.0 mm CEJ to bone) Requirement for antibiotic pre-medication prior to dental procedures Systemic antibiotic use in past 14 days to current. Use of anti-inflammatory (NSAIDs) or in past 14 days Use of anticoagulant therapy or in past 14 days. Current smokers Pregnancy Use of any oral rinses such as, but not limited to chlorhexidine, essential oils, cetylpyridinium chloride during the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo arm of non-dietary nitrate gum

    Test arm of dietary nitrate containing gum

    Arm Description

    Placebo gum with no dietary nitrate

    Functional gum with dietary nitrate

    Outcomes

    Primary Outcome Measures

    Gingival inflammation
    Gingival index or similar data collected.
    Microbiome profile
    salivary sample collected
    Blood vessel elasticity
    CV profiler device used
    nitric oxide
    Breathalyzer type test

    Secondary Outcome Measures

    Full Information

    First Posted
    August 31, 2023
    Last Updated
    August 31, 2023
    Sponsor
    University of Maryland, Baltimore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06029283
    Brief Title
    Effect on Oral-cardio Health From Dietary Nitrate Loaded Functional Gum
    Official Title
    Effect on Oral-cardio Health From Dietary Nitrate Loaded Functional Gum
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2024 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Maryland, Baltimore

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this research is to determine the effects of a chewing gum containing dietary nitrate to your gingival and heart health. Dietary nitrates are commonly found in leafy vegetables and beets. The information learned from the study may help us further understand the interconnection of oral health and heart health. The study is looking for individuals who present with mild to moderate gum irritation or bleeding. In the study participants will be randomized into either a group that will use a chewing gum containing dietary nitrate, or use a placebo chewing gum during a three-week period. Participants in the study will have a simple gingival exam, x-rays if needed, and small samples of saliva and blood collected. All participants will also undergo a routine tooth cleaning. Participants will be asked to breathe in a tube to sample the levels of nitric oxide. Finally, participants will have their heart health measured with a device that is like a blood pressure cuff.
    Detailed Description
    The purpose of the project is to characterize, in subjects with gingival inflammation, the effect of a prebiotic dietary nitrate formulated chewing gum on the oral microbiome. In order to assess this, we will observe gingival health and parameters related to vascular health: We are testing the hypothesize that short term use of functional gum will have improved inflammatory measures of the gingiva and beneficial cardiovascular impact. We endeavor to discover if any observed changes to oral and cardiovascular measures may be associated to changes to oral microbiome composition.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingivitis, Cardiovascular Diseases

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo arm of non-dietary nitrate gum
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo gum with no dietary nitrate
    Arm Title
    Test arm of dietary nitrate containing gum
    Arm Type
    Experimental
    Arm Description
    Functional gum with dietary nitrate
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    dietary nitrate
    Intervention Description
    dietary nitrate in a chewing gum delivery vehicle
    Intervention Type
    Other
    Intervention Name(s)
    Placebo chewing gum
    Intervention Description
    placebo chewing gum
    Primary Outcome Measure Information:
    Title
    Gingival inflammation
    Description
    Gingival index or similar data collected.
    Time Frame
    0 and 21 days
    Title
    Microbiome profile
    Description
    salivary sample collected
    Time Frame
    0 and 21 days
    Title
    Blood vessel elasticity
    Description
    CV profiler device used
    Time Frame
    0 and 21 days
    Title
    nitric oxide
    Description
    Breathalyzer type test
    Time Frame
    0 and 21 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult subjects with mild to moderate gingivitis, as defined with a MGI score of at least 2.0 Subjects must have a minimum of 20 natural teeth Subjects must able to chew gum Exclusion Criteria: Significant alveolar bone loss (>3.0 mm CEJ to bone) Requirement for antibiotic pre-medication prior to dental procedures Systemic antibiotic use in past 14 days to current. Use of anti-inflammatory (NSAIDs) or in past 14 days Use of anticoagulant therapy or in past 14 days. Current smokers Pregnancy Use of any oral rinses such as, but not limited to chlorhexidine, essential oils, cetylpyridinium chloride during the study.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effect on Oral-cardio Health From Dietary Nitrate Loaded Functional Gum

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