Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06029283
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2023-08-31
Brief Title:
Dietary Nitrate Functional Gum Effect on Gingivitis and Heart Health
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Effect on Oral-cardio Health From Dietary Nitrate Loaded Functional Gum
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None