Status:
COMPLETED
Dietary Nitrate Functional Gum Effect on Gingivitis and Heart Health
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Gingivitis
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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. Th...
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,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06029283
Start Date
April 15 2024
End Date
August 1 2025
Last Update
September 29 2025
Active Locations (1)
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1
University of Maryland School of Dentistry
Baltimore, Maryland, United States, 21201