Clinical trial NCT06029283: Dietary Nitrate Functional Gum Effect on Gingivitis and Heart Health
Official title: Effect on Oral-cardio Health From Dietary Nitrate Loaded Functional Gum
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gingivitis
Cardiovascular Diseases
Gingival Diseases
Gingival Bleeding
Periodontal Diseases
Keywords: gingivitis
dietary nitrate
periodontal disease
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Gingival inflammation
timeFrame: 0 and 21 days
measure: Microbiome profile
timeFrame: 0 and 21 days
measure: Blood vessel elasticity
timeFrame: 0 and 21 days
measure: nitric oxide
timeFrame: 0 and 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland School of Dentistry
state: Maryland
Study officials:
affiliation: Clinical Assoc. Prof.
name: Harlan Shiau
role: PRINCIPAL_INVESTIGATOR
References: