Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588049
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Nitrate Mouth Rinse and the Oral Microbiome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Nitrate Mouth Rinse and the Oral Microbiome
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is aimed to determine if changes to the oral microbiome occur after the use of a nitrate rich mouth rinse Participants with be asked to use either a controlled water mouthrinse once daily for 2 weeks while maintaining normal oral hygiene practices or use the nitrate rich mouthrinse once daily for 2 weeks
Primary Outcome measures
-changes in the composition of the oral microbiome
Secondary Outcome measures
Blood Pressure
Salivary Nitric Oxide Levels
Primary Outcome measures
-changes in the composition of the oral microbiome
Secondary Outcome measures
Blood Pressure
Salivary Nitric Oxide Levels
Detailed Description:
Nitrate is found in high concentrations in beet root and as such we will use a beet root based product as a daily mouth rinse Swish and Spit as a part of the participants daily oral hygiene regimen and collect the participants biofilm before and after 2 weeks of regular use We will then analyze the data using 16s rRNA sequencing to evaluate the changes in alpha diversity beta diversity and the absolute and relative differential abundance of nitrate reducing bacteria in the oral microbiome We will also collect salivary samples to evaluate NO levels as well as measure blood pressure pre and post treatment
After this studys completion we expect to have gained new knowledge on nitrates influence on the oral microbiomes composition Gaining this knowledge will allow better public understanding of the effects oral hygiene products have on their oral and systemic health In addition the knowledge gained could encourage further investigations into how to better formulate oral hygiene products for improved health and performance
After this studys completion we expect to have gained new knowledge on nitrates influence on the oral microbiomes composition Gaining this knowledge will allow better public understanding of the effects oral hygiene products have on their oral and systemic health In addition the knowledge gained could encourage further investigations into how to better formulate oral hygiene products for improved health and performance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None