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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo arm of non-dietary nitrate gum | Placebo Comparator | Placebo gum with no dietary nitrate |
|
| Test arm of dietary nitrate containing gum | Experimental | Functional gum with dietary nitrate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dietary nitrate | Dietary Supplement | dietary nitrate in a chewing gum delivery vehicle |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harlan Shiau | Clinical Assoc. Prof. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland School of Dentistry | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D002318 | Cardiovascular Diseases |
| D005882 | Gingival Diseases |
| D005884 | Gingival Hemorrhage |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D006472 | Oral Hemorrhage |
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| Placebo chewing gum | Other | placebo chewing gum |
|
| D006470 |
| Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |