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

Study Overview
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Brief Summary
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The purpose of this research is to determine the effects of a chewing gum containing dietary nitrate to gingival and heart health. Dietary nitrates are commonly found in leafy vegetables and beets. The information learned from the study may help 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
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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, gingival health and parameters related to vascular health are observed: The study is testing the hypothesize that short term use of functional gum will have improved inflammatory measures of the gingiva and beneficial cardiovascular impact. The study hopes to discover if any observed changes to oral and cardiovascular measures may be associated to changes to oral microbiome composition.

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

Conditions
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Gingivitis, Cardiovascular Diseases

Intervention / Treatment
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* Dietary Supplement: dietary nitrate
* Other: Placebo chewing gum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult subjects with mild to moderate gingivitis, defined with a MGI score of at least 2.0 Subjects must have a minimum of 20 natural teeth Subjects must be 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo arm of non-dietary nitrate gum<br>Placebo gum with no dietary nitrate | Other: Placebo chewing gum<br>* placebo chewing gum<br>|
| Experimental: Test arm of dietary nitrate containing gum<br>Functional gum with dietary nitrate | Dietary Supplement: dietary nitrate<br>* dietary nitrate in a chewing gum delivery vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival inflammation | Gingival index or similar data collected. | 0 and 21 days | 
| Microbiome profile | salivary sample collected | 0 and 21 days | 
| Blood vessel elasticity | CV profiler device used | 0 and 21 days | 
| nitric oxide | Breathalyzer type test | 0 and 21 days |