Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358924
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2024-04-06
Brief Title:
Effect of Different Desensitizing Agents on Post-bleaching Hypersensitivity and Shade Stability
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
The Effect of Different Desensitizing Agents on Post-bleaching Hypersensitivity Shade Stability and Surface Properties of Bleached Enamel An In-vitro and In-vivo Study
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 compared the effect of four different desensitizing agents on shade stability and dental hypersensitivity following dental bleaching procedure The follow-up periods ranged from 24 hours to 1 year
Detailed Description:
This study was conducted to assess the effectiveness of 4 different desensitizing agents used after dental bleaching regarding dental hypersensitivity and shade stability It was a double-blinded randomized clinical trial
The ethical approval was obtained in May 2020 by the Research Ethics Committee an Institutional Review Board Faculty of Dentistry Ain Shams University FDASU-REC
The number of patients was determined according to G-Power program with a power 1-β error of 08 Power 80 and 95 confidence level α 005 using a two-sided hypothesis test According to sample size calculation 40 patients were needed for this study n10 per group
Patients were selected according to inclusion and exclusion criteria and were randomly assigned into 4 groups according to the desensitizing agent used The 4 desensitizing agents were After Whitening Mousse Mi Paste Plus Hydroxyapatite and Fluoride ReminPro and PAMAM
Patients signed an informed consent and received a detailed explanation of the study procedures Baseline dental shade was recorded using Vita Easy-Shade spectrophotometer and Vita Classical Shade guide Baseline sensitivity was assessed and recorded using a VAS
All patients received dental bleaching using In-office chemically activated Power Whitening YF WHITEsmile Germany followed by a desensitizing procedure using the desensitizing agent assigned to the specific experimental group
Dental shade and dental hypersensitivity was assessed at different follow-up appointments 24-hours 3 days 1 week 1 month 3 months 6 months 9 months and 1 year following the procedures
Assessment of these variables at follow-up appointments was performed by 2 external assessors and patients were blinded to the type desensitizing agent used
The ethical approval was obtained in May 2020 by the Research Ethics Committee an Institutional Review Board Faculty of Dentistry Ain Shams University FDASU-REC
The number of patients was determined according to G-Power program with a power 1-β error of 08 Power 80 and 95 confidence level α 005 using a two-sided hypothesis test According to sample size calculation 40 patients were needed for this study n10 per group
Patients were selected according to inclusion and exclusion criteria and were randomly assigned into 4 groups according to the desensitizing agent used The 4 desensitizing agents were After Whitening Mousse Mi Paste Plus Hydroxyapatite and Fluoride ReminPro and PAMAM
Patients signed an informed consent and received a detailed explanation of the study procedures Baseline dental shade was recorded using Vita Easy-Shade spectrophotometer and Vita Classical Shade guide Baseline sensitivity was assessed and recorded using a VAS
All patients received dental bleaching using In-office chemically activated Power Whitening YF WHITEsmile Germany followed by a desensitizing procedure using the desensitizing agent assigned to the specific experimental group
Dental shade and dental hypersensitivity was assessed at different follow-up appointments 24-hours 3 days 1 week 1 month 3 months 6 months 9 months and 1 year following the procedures
Assessment of these variables at follow-up appointments was performed by 2 external assessors and patients were blinded to the type desensitizing agent used
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