Ignite Creation Date:
2024-05-06 @ 4:03 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04855279
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2021-04-19
Brief Title:
Prevention of Bleaching Induced Sensitivity
Sponsor:
Medipol University
Organization:
Medipol University
Study Overview
Official Title:
Effectiveness of Remineralization Agents on the Prevention of Dental Bleaching Induced Sensitivity
Status:
COMPLETED
Status Verified Date:
2021-04
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 aims to evaluate the use of different desensitizing agents before in-office bleaching A total of 64 volunteers were randomly divided into four groups Before undergoing in-office bleaching with 38 hydrogen peroxide gel three applications of 15 minutes each one session clinicians applied a placebo gel control group casein phosphopeptide-amorphous calcium phosphate CPP-ACP neutral sodium fluoride gel NSF or nano-hydroxyapatite solution n-HAP on all buccal surfaces of teeth The gel was left undisturbed for 4 minutes Patients recorded their tooth sensitivities on the VAS scale Kruskal-Wallis test followed by Mann-Whitney U test were used to compare changes in tooth color and intensity of tooth sensitivity between groups
Detailed Description:
Color evaluation was performed with Vita Shade Guide Classical Vitapan Classical Vita Bad Sakingen Germany The shades were evaluated with shade guide units SGUs Vita Classical Shade Guide consisted of 16 shades and the shades were aligned light-to-dark from B1-C421 22 The shades were taken before and after 24 hours and 7 days of treatmentNext the hypersensitivity was recorded by asking each subject to establish his or her perception of sensitivity before treatment using a visual analog scale VAS A stimulus of an evaporative blowing triple syringe 25 psi at ambient conditions was applied for 3 seconds on the upper central incisors from a distance of 1 cm After 24 hours and 7 days of bleaching treatment stimuli testing was performed againThe subjects were divided into four groups Group 1 Subjects were treated with a placebo gel The agent was applied for 4 min to all the teeth to be bleached Group 2 Subjects were treated with ACP-CCP gel Tooth Mousse GC Corp Tokyo Japan for 4 min to all the teeth to be bleached Group 3 Subjects were treated with nano-hydroxyapatite solution for 4 min to all the teeth to be bleached Group 4 Subjects were treated with neutral sodium fluoride NSF gel for 4 min to all the teeth to be bleached After treatment the agent was removed by washing with water in all groups Each subject underwent one session of bleaching on the anterior teeth from canine-to-canine Bleaching systems were applied according to the manufacturers instructions by one of the authors Subjects were treated with hydrogen peroxide at 38 activated by a light source composed of 12 LEDs with blue light generators The calculated hypersensitivity values and color change values were tested with Shapiro-Wilk and Levene tests for normal data distribution and homogeneity of variances Kruskal-Wallis test followed by Mann-Whitney U test was performed to compare groups
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?:
None
Is an FDA AA801 Violation?:
None