Dietary Nitrate Functional Gum Effect on Gingivitis and Heart Health

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06029283
• Other study ID #: HP-00106795
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: April 2024
• Source: University of Maryland, Baltimore
• Contact: Harlan Shiau
• Phone: 410-706-7152
• Email: chewgum4gum[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 30, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Gingival Bleeding
• Gingival Diseases
• Gingival Hemorrhage
• Gingivitis
• Periodontal Diseases

Intervention

Dietary Supplement:
• dietary nitrate
dietary nitrate in a chewing gum delivery vehicle

Other:
• Placebo chewing gum
placebo chewing gum

Locations

Country	Name	City	State
United States	University of Maryland School of Dentistry	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival inflammation	Gingival index or similar data collected.	0 and 21 days
Primary	Microbiome profile	salivary sample collected	0 and 21 days
Primary	Blood vessel elasticity	CV profiler device used	0 and 21 days
Primary	nitric oxide	Breathalyzer type test	0 and 21 days