Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607172
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Clinical Efficacy of the Combined Effect of Oral Irrigator and Chemicals 0075 CPC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Antiplaque and Antigingivitis Efficacy of the Combined Effect of Oral Irrigator and Chemicals 0075 CPC a Randomized Clinical Trial with Experimental Gingivitis Model
Status:
NOT_YET_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:
WFPOC
Brief Summary:
This is an experimental gingivitis clinical study to evaluate gum health efficacy from the combination effect of water flosser and chemistry 0075 CPC compared to water flosser and water and to no oral hygiene regimen with a 3-week follow-up Thirty participants aged between 18 and 70 will be enrolled
Detailed Description:
This is an examiner blind randomized controlled parallel designed clinical study that aims to assess the gum health efficacy antiplaque and antigingivitis from the combination effect of water flosser and chemistry 0075 CPC compared to water flosser and water and to no oral hygiene in a 3-week experimental gingivitis Thirty participants will be enrolled and allocated into 3 groups group I - using a water flosser device and water each time group II - using a water flosser device and dilutable chemistry product 0075 CPC after dilution each time for groups I an II participants will use this regimen treatment twice daily in the morning and evening and no other oral hygiene will be allowed during the 21 days of follow-up group III - negative control in which participants will abstain for any oral hygiene during the 21 days of follow-up Gingival index measurements will be the primary efficacy variable after using the assigned regimen for 3 weeks for each subject Subjects will under go baseline 3 days 1 2 and 3 weeks visits An Analysis of Covariance will be performed on the final or delta plaque scores using the baseline value as covariate The F-test in this analysis will test the hypothesis that the waterflosser groups are equal in adjusted means
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