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Dietary Supplement

Test arm of dietary nitrate containing gum for Gum Bleeding

N/A

Recruiting

Led By Harlan Shiau

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult subjects with mild to moderate gingivitis, defined with a MGI score of at least 2.0

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 and 21 days

Awards & highlights

Study Summary

This trial aims to see if chewing gum with dietary nitrate can improve gum and heart health. They are looking for people with mild to moderate gum issues to participate. Participants will be split into two groups

Who is the study for?

This trial is for adults with mild to moderate gum disease, evidenced by a specific gingivitis score and having at least 20 natural teeth. Participants must be able to chew gum. It's not specified who can't join because the exclusion criteria are missing.Check my eligibility

What is being tested?

The study tests if chewing gum with dietary nitrate improves oral and heart health compared to placebo gum. Participants will be randomly assigned to one of these two groups for three weeks, undergo dental exams, saliva and blood sampling, breath analysis for nitric oxide levels, and heart health assessments.See study design

What are the potential side effects?

Potential side effects aren't detailed in the provided information but could include discomfort from dental procedures or reactions from ingredients in the test or placebo gums.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have mild to moderate gum disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 and 21 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 and 21 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 and 21 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Blood vessel elasticity

Gingival inflammation

Microbiome profile

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Test arm of dietary nitrate containing gumExperimental Treatment1 Intervention

Functional gum with dietary nitrate

Group II: Placebo arm of non-dietary nitrate gumPlacebo Group1 Intervention

Placebo gum with no dietary nitrate

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

689 Previous Clinical Trials

374,656 Total Patients Enrolled

Harlan ShiauPrincipal InvestigatorClinical Assoc. Prof.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment of participants still ongoing for this clinical trial?

"Based on information available through clinicaltrials.gov, this medical research investigation is presently seeking eligible candidates. The trial was first listed on 4/15/2024 and last revised on 4/16/2024."

Answered by AI

What is the current number of individuals being recruited as participants in this clinical study?

"Indeed, information available on clinicaltrials.gov indicates that this particular medical research study is actively seeking individuals to participate. The trial was originally posted on April 15th, 2024 and was last revised on April 16th, 2024. This investigation aims to enroll a total of 30 participants from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dietary Nitrate Functional Gum Effect on Gingivitis and Heart Health

Harlan Shiau 2024. "Dietary Nitrate Functional Gum Effect on Gingivitis and Heart Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06029283.