NCT06029283

Dietary Nitrate Functional Gum Effect on Gingivitis and Heart Health

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Gingivitis
• Cardiovascular Diseases
• Gingival Diseases
• Gingival Bleeding
• Periodontal Diseases

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	dietary nitrate	dietary nitrate in a chewing gum delivery vehicle
OTHER	Placebo chewing gum	placebo chewing gum

Timeline

• Start date: 2024-04-15
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2023-09-08
• Last updated: 2025-09-29

Locations

1 site across 1 country: United States