Dietary Nitrate Functional Gum Effect on Gingivitis and Heart Health

NCT06029283 | Completed

• 1 other identifier: HP-00106795
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

gingivitis; dietary nitrate; periodontal disease

Outcome Measures

Primary Outcomes (4)

• Gingival inflammation

  Gingival index or similar data collected.

  0 and 21 days

• Microbiome profile

  salivary sample collected

  0 and 21 days

• Blood vessel elasticity

  CV profiler device used

  0 and 21 days

• nitric oxide

  Breathalyzer type test

  0 and 21 days

Study Arms (2)

Placebo arm of non-dietary nitrate gum

PLACEBO COMPARATOR

Placebo gum with no dietary nitrate

Other: Placebo chewing gum

Test arm of dietary nitrate containing gum

EXPERIMENTAL

Functional gum with dietary nitrate

Dietary Supplement: dietary nitrate

Interventions

dietary nitrate DIETARY_SUPPLEMENT

dietary nitrate in a chewing gum delivery vehicle

Test arm of dietary nitrate containing gum

Placebo chewing gum OTHER

placebo chewing gum

Placebo arm of non-dietary nitrate gum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland School of Dentistry

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Gingivitis; Cardiovascular Diseases; Gingival Diseases; Gingival Hemorrhage; Periodontal Diseases

Condition Hierarchy (Ancestors)

Infections; Mouth Diseases; Stomatognathic Diseases; Oral Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Harlan Shiau

  Clinical Assoc. Prof.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor / program director

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 8, 2023
• Study Start: April 15, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)