Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04537754
Status:
COMPLETED
Last Update Posted:
2020-09-04
First Post:
2020-07-08
Brief Title:
Clinical Comparison of LED- and Diode Laser-activated Bleaching
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
Clinical Comparison of LED- and Diode Laser-activated Bleaching
Status:
COMPLETED
Status Verified Date:
2020-09
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:
To clinically compare the effects of LED- or Diode laser-activated bleaching on colour change tooth-sensitivity gingival-irritation and temperature variation over 9-months
Thirty-five patients with tooth colour A2 or higher will be included in the study In a split-mouth design using a 35 HP bleaching agent Whiteness HP one side of each mouth will be randomly activated by a diode laser Epic X and the other side by an LED Radii Plus light-source During bleaching the temperature variations will be recorded using a thermocouple from the buccal surface of canine teeth Colour change ΔSGU ΔE will be evaluated by subjective Vita classicbleached guide and objective methods spectrophotometry before treatment and immediately 48h 1 week 1 6 9 months after Tooth-sensitivity and gingival- irritation will be assessed by visual analogue scale VAS and Gingival Index
Thirty-five patients with tooth colour A2 or higher will be included in the study In a split-mouth design using a 35 HP bleaching agent Whiteness HP one side of each mouth will be randomly activated by a diode laser Epic X and the other side by an LED Radii Plus light-source During bleaching the temperature variations will be recorded using a thermocouple from the buccal surface of canine teeth Colour change ΔSGU ΔE will be evaluated by subjective Vita classicbleached guide and objective methods spectrophotometry before treatment and immediately 48h 1 week 1 6 9 months after Tooth-sensitivity and gingival- irritation will be assessed by visual analogue scale VAS and Gingival Index
Detailed Description:
Objective The aim of this split-mouth randomized clinical study is to evaluate the effect of LED or Diode laser-activated bleaching applications on colour change tooth sensitivity gingival irritation and temperature variation with 35 hydrogen peroxide bleaching gel after 9 months Material and Methods Thirty-five patients with anterior teeth without caries and no restoration will be included in this study In a split-mouth design a bleaching agent containing 35 HP Whiteness HP FGM will be used one side of each jaw will be activated by a diode laser Epic X Biolase and the other side will be activated by an LED Radii Plus SDI light source During the bleaching treatments the temperature variations will be recorded using a thermocouple DT-3891G K type Thermometer datalogger CEM Instruments from the buccal surface of canine teeth Tooth sensitivity will be assessed by Visual Analogue Scale VAS before the treatment and during immediately 48 hours 1 week 1 6 and 9 months after Color change will be evaluated by subjective Vita Classic and Vita 3D Master Bleachguide and objective methods Vita Easy Shade spectrophotometer before the treatment and immediately 48 hours 1 week 1 6 and 9 months after Color change ΔE and ΔSGU will be performed by analysis of variance in repeated measurements Multiple comparisons will be evaluated by Bonferroni test Temperature variation will be evaluated by t-test in dependent groups Tooth sensitivity will be analyzed using Friedman test Wilcoxon test will be used to compare two light sources Diode Laser LED in each time period p 005
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