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OpenTrials
Completed

NCT Number: NCT06029283

Dietary Nitrate Functional Gum Effect on Gingivitis and Heart Health

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland School of Dentistry

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary nitrate

Dietary Supplement

dietary nitrate in a chewing gum delivery vehicle

Placebo chewing gum

Other

placebo chewing gum

Primary outcomes

  1. Gingival inflammation

    Time frame: 0 and 21 days

    Gingival index or similar data collected.

  2. Microbiome profile

    Time frame: 0 and 21 days

    salivary sample collected

  3. Blood vessel elasticity

    Time frame: 0 and 21 days

    CV profiler device used

  4. nitric oxide

    Time frame: 0 and 21 days

    Breathalyzer type test

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2023
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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