Dietary Nitrate Functional Gum Effect on Gingivitis and Heart Health

Not Applicable

Active, not recruiting

• Conditions: Gingivitis; Gingival Diseases; Gingival Bleeding; Cardiovascular Diseases; Periodontal Diseases
• Interventions: Other: Placebo chewing gum; Dietary Supplement: dietary nitrate

• Registration Number: NCT06029283
• Lead Sponsor: University of Maryland, Baltimore

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. 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.

Study Timeline

• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-08-31
• Study First Posted: 2023-09-08
• Study Start: 2024-04-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-28
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo arm of non-dietary nitrate gum	Placebo chewing gum	Placebo gum with no dietary nitrate
Test arm of dietary nitrate containing gum	dietary nitrate	Functional gum with dietary nitrate

Primary Outcome Measures

Name	Time	Method
Gingival inflammation	0 and 21 days	Gingival index or similar data collected.
Microbiome profile	0 and 21 days	salivary sample collected
Blood vessel elasticity	0 and 21 days	CV profiler device used
nitric oxide	0 and 21 days	Breathalyzer type test

Trial Locations

Locations (1)

University of Maryland School of Dentistry; 🇺🇸 Baltimore, Maryland, United States