Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05835453
Status:
RECRUITING
Last Update Posted:
2023-09-13
First Post:
2023-04-18
Brief Title:
At-home Bleaching Using Clear Aligners
Sponsor:
Universidad Rey Juan Carlos
Organization:
Universidad Rey Juan Carlos
Study Overview
Official Title:
At-home Bleaching With the Use of Clear Aligners Randomized Single-blind Equivalence Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-09
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:
The aim of the present project is to clinically evaluate the bleaching effectiveness tooth sensitivity gingival irritation and patients satisfaction during a at-home bleaching with 10 carbamide peroxide using a conventional bleaching tray or a clear aligner
Detailed Description:
Forty patients n40 will be randomized as to which side will receive the type of bleaching tray conventional or clear aligner The at-home bleaching will be performed with 10 carbamide peroxide Opalescence PF 10 for 2 hours for 4 weeks The color will be assessed at baseline after one two four weeks and at 1 month after bleaching treatment using subjective color guides VITA Classical and VITA Bleachguide 3D-MASTER and a objective digital spectrophotometer VITA Easyshade The intensity and absolute risk of tooth sensitivity and gingival irritation will also be determined with a visual analog scale EVA 0-10 Patients satisfaction will be evaluated at baseline after one and two weeks and at 1 month after bleaching treatment with an apropriate questionnaire using a visual analog scale EVA 0-10 Color change between groups will be compared by paired Students t-test The absolute risk of tooth sensitivity and gingival irritation for both groups will be compared by McNemar test Also odds ratios confidence intervals and Spearman correlation will be determined The intensity of tooth sensitivity gingival irritation and patients satisfaction will be compared by paired Students t-test The level of statistical significance accepted will be 5 for all analyses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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