Dietary Nitrate Functional Gum Effect on Gingivitis and Heart Health

NCT ID: NCT06029283

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2025-08-01

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.

Conditions

Gingivitis; Cardiovascular Diseases; Gingival Diseases; Gingival Bleeding; Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Placebo arm of non-dietary nitrate gum

Placebo gum with no dietary nitrate

Group Type: PLACEBO_COMPARATOR

Placebo chewing gum

Intervention Type: OTHER

placebo chewing gum

Test arm of dietary nitrate containing gum

Functional gum with dietary nitrate

Group Type: EXPERIMENTAL

dietary nitrate

Intervention Type: DIETARY_SUPPLEMENT

dietary nitrate in a chewing gum delivery vehicle

Interventions

dietary nitrate

dietary nitrate in a chewing gum delivery vehicle

Intervention Type: DIETARY_SUPPLEMENT

Placebo chewing gum

placebo chewing gum

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Harlan Shiau

Clinical associate professor / program director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harlan Shiau

Role: PRINCIPAL_INVESTIGATOR

Clinical Assoc. Prof.

Locations

University of Maryland School of Dentistry

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HP-00106795

Identifier Type: -

Identifier Source: org_study_id