Ignite Creation Date:
2024-05-06 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03688893
Status:
COMPLETED
Last Update Posted:
2018-10-19
First Post:
2018-09-21
Brief Title:
Efficacy of Laser Application in Dental Bleaching
Sponsor:
Universidad Nacional de Caaguazu
Organization:
Universidad Nacional de Caaguazu
Study Overview
Official Title:
Efficacy of Laser Application in Dental Bleaching A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2018-10
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:
Objective To establish the efficacy of laser application with chemical treatment in dental bleaching compared to chemical treatment alone
Methods The investigators conducted a randomized controlled trial RCT single blind evaluator in 24 patients randomized to laser and chemical intervention 12 or chemical intervention aloe 12 The commercial products used were Whiteness Hp 35 Hydrogen Peroxide and the LASER of DCM Equipments The trial outcome measures were obtained using the Vita EasyShade Spectrophotometer and the International CIELCh system To stablish differences before vs after treatments and between groups the T test and chi2 tests were applied
Methods The investigators conducted a randomized controlled trial RCT single blind evaluator in 24 patients randomized to laser and chemical intervention 12 or chemical intervention aloe 12 The commercial products used were Whiteness Hp 35 Hydrogen Peroxide and the LASER of DCM Equipments The trial outcome measures were obtained using the Vita EasyShade Spectrophotometer and the International CIELCh system To stablish differences before vs after treatments and between groups the T test and chi2 tests were applied
Detailed Description:
New technologies continue to be launched in the field of dental esthetics especially for whitening and many products advertise their efficacy One new approach is the use of LASER technology which has been purported to be the most powerful font light for bleaching Diverse studies by different designs find different efficacies for LASER whitening Randomized clinical trials RCT are needed for the most rigorous confirmation of efficacy RCT are able to control for characteristics that can cause bias including factors related to dental care such as diet and cleaning behavior after the bleaching procedure The investigators therefore conducted an RCT to make a side by side comparison of a LASER whitening technique with chemical bleaching versus chemical bleaching without LASER
Intervention After the patient was informed and sign the consent a dental prophylaxis was done Three days later the bleaching procedure started following the same protocol regarding to the time and product used 35 Hydrogen Peroxide Whitening HP 40 minutes divided in two phases of 20 minutes each one from premolar to premolar in superior and inferior teeth The difference was that one of the intervention groups used the Laser for ten minutes starting at the minute 5 and the other did not The Laser used was the Whitening Lase II DCM EQUIPMENTS
The measure of the color was done to the superior canines by just one evaluator in three stages before bleaching baseline 15 minutes after bleaching and three days after It was done with the Vita Easyshade Spectrophotometer
The dental sensitivity also was asked at the three time points however as an exclusion criterion the level had to be 0 to be entered into the study
All the patients received verbal and written instructions about eating and cleaning behavior Cleaning materials for the three days after procedure were given
As the clinical endpoint the difference in color was calculated using the international accepted system CIELCh 1118-19 The formula is E L2 C2 h2 ½ were L is Luminosity C is Chroma and h is Hue
A verbal numeric scale was used to determine the dental sensitivity with values from 0 to 3 The evaluator used the water and air from the dental chair syringe The patient reports 0 for no sensitivity 1 for slight sensitivity 2 for moderate sensitivity and 3 for severe sensitivity
Intervention After the patient was informed and sign the consent a dental prophylaxis was done Three days later the bleaching procedure started following the same protocol regarding to the time and product used 35 Hydrogen Peroxide Whitening HP 40 minutes divided in two phases of 20 minutes each one from premolar to premolar in superior and inferior teeth The difference was that one of the intervention groups used the Laser for ten minutes starting at the minute 5 and the other did not The Laser used was the Whitening Lase II DCM EQUIPMENTS
The measure of the color was done to the superior canines by just one evaluator in three stages before bleaching baseline 15 minutes after bleaching and three days after It was done with the Vita Easyshade Spectrophotometer
The dental sensitivity also was asked at the three time points however as an exclusion criterion the level had to be 0 to be entered into the study
All the patients received verbal and written instructions about eating and cleaning behavior Cleaning materials for the three days after procedure were given
As the clinical endpoint the difference in color was calculated using the international accepted system CIELCh 1118-19 The formula is E L2 C2 h2 ½ were L is Luminosity C is Chroma and h is Hue
A verbal numeric scale was used to determine the dental sensitivity with values from 0 to 3 The evaluator used the water and air from the dental chair syringe The patient reports 0 for no sensitivity 1 for slight sensitivity 2 for moderate sensitivity and 3 for severe sensitivity
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?:
False
Is an FDA AA801 Violation?:
None