Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598072
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Comparative Study to Evaluate the Efficacy of an Alcohol-free Mouthwash Regimen with CPCZn Flossing and Brushing and an Alcohol-based Mouthwash Regimen with Essential Oils in Reducing Plaque and Gingivitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Study to Evaluate the Efficacy of a Regimen Including Rinsing with an Alcohol Free Mouthwash Containing CPCZn As Compared to Dental Flossing and Brushing and a Regimen Including Rising with an Essential Oils Containing Alcohol Mouthwash in Reducing Dental Plaque and Gingivitis
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:
PGMWII
Brief Summary:
This is a Phase III randomized one-center parallel group double blinded clinical study to evaluate the efficacy of an alcohol-free mouthwash containing CPCZn as compared to dental flossing and to rising with an essential oils containing alcohol mouthwash in reducing dental plaque and gingivitis One hundred and twenty participants aged between 18 and 65 years will be included and followed for 12 weeks
Detailed Description:
This clinical study aims to evaluate the efficacy of a regimen including an alcohol-free mouthwash containing CPCZn as compared to dental flossing and brushing and to a regimen including a rinsing with an essential oils containing alcohol mouthwash in reducing dental plaque and gingivitis This is a Phase III randomized one-center parallel group double blinded involving 120 participants aged 18 to 65 Subjects will be allocated into 3 groups one - using the CPCZn mouthwash another using the essential oils mouthwash and a control group using dental floss Each group will also use a fluoride toothpaste and a soft-bristle toothbrush twice daily over 12 weeks The primary efficacy variable is the reduction of gingival inflammation also Probing Depth Bleeding on Probing and a Plaque Index will be accessed Subjects will undergo baseline 4-week and 12-week evaluations with data analyzed using ANCOVA to assess the efficacy and safety of the products Adverse events and compliance will be closely monitored with strict confidentiality maintained for all participants The study rigorous design aims to provide comprehensive insights into the effectiveness of these oral hygiene regimens
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