Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04626778
Status:
COMPLETED
Last Update Posted:
2021-01-20
First Post:
2020-11-05
Brief Title:
Clinical Efficacy of Single-Use of Peroxyl Mouthwash for Reducing Bacteria in Saliva and Bioaerosol Contamination
Sponsor:
Colgate Palmolive
Organization:
Colgate Palmolive
Study Overview
Official Title:
Clinical Efficacy of Single-Use of Peroxyl Mouthwash for Reducing Bacteria in Saliva and Bioaerosol Contamination Phase I
Status:
COMPLETED
Status Verified Date:
2020-11
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:
To evaluate the anti-bacterial pre-procedural clinical efficacy of Peroxyl mouthwash 15 hydrogen peroxide in saliva and the reduction of bioaerosol contamination as compared to a matching placebo mouthwash 00 hydrogen peroxide
Detailed Description:
Qualified subjects will be enrolled and randomized to either one of the two study groups balanced on the basis of their initial gingival index scores Saliva samples will be collected from participants prior to rinsing with their assigned mouthwash 15 hydrogen peroxide or 00 hydrogen peroxide for one minute and then expectorate Saliva samples will again be collected immediately after at 30 min and 60 min after rinsing All collected saliva samples will be placed in sterile vials labeled with subject information and transferred to the microbiology laboratory for analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None