Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358911
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2024-04-06
Brief Title:
A Clinical Study for the Effect of 4th Generation Poly AmidoAmine Dendrimer on Post-Bleaching Hypersensitivity and Shade Stability
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
A Clinical Study for the Effect of 4th Generation Poly Amido Amine Dendrimer PAMAM-COOH Desensitizing Agent on Post-Bleaching Hypersensitivity and Shade Stability of Patients Subjected to Bleaching Treatment
Status:
COMPLETED
Status Verified Date:
2024-04
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:
This study assessed the impact of four desensitizing agents on both color stability and dental sensitivity following a bleaching procedure spanning from the 24-hour to the 1-year follow-up assessment periods
Detailed Description:
Dental bleaching is a temporary treatment with potential adverse effects on dental sensitivity post-procedure Therefore the study aimed to evaluate dental color stability and sensitivity over a one-year period following bleaching utilizing one of four desensitizing agents PAMAM MI Paste Plus Hydroxyapatite and F ReminPro and Ultra EZ The selection of the desensitizing agent was based on a predetermined randomization sequence generated in Microsoft Excel Color stability was objectively assessed through spectrophotometric analysis while subjective evaluation was conducted using the Vita Classic shade guide by two external observers not involved in the procedure Dental sensitivity levels were tracked at various intervals using a visual analogue scale Baseline measurements for both sensitivity and color stability were taken before the bleaching procedure with subsequent evaluations at 24 hours 3 days 1 week 1 month 3 months 6 months 9 months and 1 year post-bleaching The study involved 60 patients from Ain Shams University seeking dental whitening treatment divided into four groups based on the randomization sequence
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