GingivitisNCT06029283
Dietary Nitrate Functional Gum Effect on Gingivitis and Heart Health
A study testing dietary nitrate in people with Gingivitis and Cardiovascular Diseases, run by University of Maryland, Baltimore at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingivitis, Cardiovascular Diseases, Gingival Diseases
- What is being tested?
- dietary nitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Dentistry
Baltimore, Maryland, 21201
About this study
Official title: 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.
Read the 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
- Being tested
- dietary nitrate, Placebo chewing gum
- Keywords
- gingivitis, dietary nitrate, periodontal disease
- Medical subject headings
- Gingivitis, Cardiovascular Diseases, Gingival Diseases, Gingival Hemorrhage, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary nitrateDietary supplement
dietary nitrate in a chewing gum delivery vehicle
Placebo chewing gumOther
placebo chewing gum
| Study group | Role | What they receive |
|---|---|---|
| Placebo arm of non-dietary nitrate gum | Placebo comparator | Placebo gum with no dietary nitrate Receives: Other: Placebo chewing gum |
| Test arm of dietary nitrate containing gum | Experimental | Functional gum with dietary nitrate Receives: Dietary Supplement: dietary nitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival inflammation
Gingival index or similar data collected.
Measured: 0 and 21 days
Microbiome profile
salivary sample collected
Measured: 0 and 21 days
Blood vessel elasticity
CV profiler device used
Measured: 0 and 21 days
nitric oxide
Breathalyzer type test
Measured: 0 and 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start15 Apr 2024
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harlan Shiau, University of Maryland, Baltimore
- Investigators
- Harlan Shiau, Principal investigator, Clinical Assoc. Prof.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029283
- Sponsor's protocol ID
- HP-00106795
- Status last verified
- Sep 2025
- First submitted
- 31 Aug 2023
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Oral-cardio Health From Dietary Nitrate Loaded Functional Gum
- ClinicalTrials.gov ID
- NCT06029283
- Acronym / sponsor ID
- HP-00106795
- Conditions
- Gingivitis, Cardiovascular Diseases, Gingival Diseases, Gingival Bleeding, Periodontal Diseases
- Keywords
- gingivitis, dietary nitrate, periodontal disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo arm of non-dietary nitrate gum | Placebo comparator | Other: Placebo chewing gumPlacebo gum with no dietary nitrate |
| Test arm of dietary nitrate containing gum | Experimental | Dietary Supplement: dietary nitrateFunctional gum with dietary nitrate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary nitratedietary nitrate in a chewing gum delivery vehicle | Dietary supplement | Test arm of dietary nitrate containing gum |
| Placebo chewing gumplacebo chewing gum | Other | Placebo arm of non-dietary nitrate gum |
Primary outcome
Gingival inflammation
Time frame: 0 and 21 days
Gingival index or similar data collected.
Microbiome profile
Time frame: 0 and 21 days
salivary sample collected
Blood vessel elasticity
Time frame: 0 and 21 days
CV profiler device used
nitric oxide
Time frame: 0 and 21 days
Breathalyzer type test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Gingivitis
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Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
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A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
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Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
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Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harlan Shiau principal investigator
Clinical Assoc. Prof.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary nitrate in people with Gingivitis and Cardiovascular Diseases, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival inflammation (time frame: 0 and 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.