Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04717063
Status:
COMPLETED
Last Update Posted:
2021-01-20
First Post:
2021-01-19
Brief Title:
Clinical Efficacy of Single-Use of Peroxyl Mouthwash for Reducing Bacteria Saliva and Bioaerosol Contamination Phase 2
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 2
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 antibacterial efficacy of a commercial mouthwash containing 15 hydrogen peroxide in reducing the levels of bacteria in bioaerosols generated by dental prophylaxis
Detailed Description:
Following a washout period subjects will return to the clinical site A baseline microbial sample will be collected from the operatorys atmosphere for 30 min prior to the study subject appointment by placing blood agar plates on a support board attached to the bracket chair tray Upon completion of a half-mouth eg right side dental prophylaxis each study subject will be instructed to rinse for one minute with 10 ml of one of the two mouthwash solutions 15 hydrogen peroxide or 00 hydrogen peroxide and to expectorate all remaining liquid Next the dental prophylaxis will be completed on the other side of the mouth Bioaerosol samples will be collected prior to and following rinsing on blood agar plates placed on a support board at a 50-degree angle to the participants chest on the participants chest and on the examiners forehead Plates will be closed and labeled The plates will be transferred to the microbiology laboratory for analysis All subjects will be followed for adverse events throughout the study
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