Dietary Nitrate Functional Gum Effect on Gingivitis and Heart Health

April 20, 2024 updated by: Harlan Shiau, University of Maryland, Baltimore

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland School of Dentistry
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo arm of non-dietary nitrate gum
Placebo gum with no dietary nitrate
Other: Placebo chewing gum
placebo chewing gum
Experimental: Test arm of dietary nitrate containing gum
Functional gum with dietary nitrate
Dietary supplement: dietary nitrate
dietary nitrate in a chewing gum delivery vehicle

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Investigators

  • Principal Investigator: Harlan Shiau, Clinical Assoc. Prof.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

August 31, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 20, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00106795

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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