Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06608368
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
A Clinical Study Assessing the Effects of a Marketed Dentifrice on Tooth Sensitivity While Undergoing Tooth Bleaching
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Clinical Study Assessing the Effects of a Marketed Dentifrice Compared to a Regular Fluoride Dentifrice and a Positive Control Dentifrice on Tooth Sensitivity While Undergoing Tooth Bleaching
Status:
RECRUITING
Status Verified Date:
2024-10
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 aim of this study is to investigate the efficacy of a marketed dentifrice containing 5 percent NovaMin Calcium Sodium Phosphosilicate to reduce tooth sensitivity during and post tooth bleaching compared to a marketed dentifrice containing 5 potassium nitrate KNO3 and a marketed regular fluoride-containing dentifrice
Detailed Description:
This is a randomized examiner blind single-center controlled three arm parallel group proof-of-principal study to evaluate tooth sensitivity during and following a course of at-home tooth bleaching in participants with and without clinically confirmed dentine hypersensitivity DH The study will recruit generally healthy participants who wish to undergo peroxide tooth bleaching Sufficient participants will be screened to randomize approximately 90 participants to study treatment approximately 30 per treatment group
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