Ignite Creation Date:
2024-05-06 @ 10:15 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03207204
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2017-06-22
Brief Title:
In-office Bleaching Using a Violet Light
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Long-term Clinical Evaluation of In-office Dental Bleaching Using a Violet Light 405-410 nm
Status:
COMPLETED
Status Verified Date:
2020-11
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:
The objective of this clinical study is to evaluate the effect of the whitening treatment performed with the violet LED light 405-410 nm with or without a bleaching gel on the tooth color changes immediate and long-term tooth sensitivity satisfaction of participants in relation to the technique and impact on their quality of life After being informed of the objectives of the study 200 participants will be selected and randomly divided into a treatment group n 25 G1 - 35 hydrogen peroxide HP 4 sessions 1 sessionweek G2 - 30 carbamide peroxide CP 4 sessions 1 sessionweek G3 - Violet LED 405-410 nm 4 sessions 1 sessionweek G4 - Violet LED 405-410 nm 4 sessions 2 sessionsweek G5 - Violet LED associated to 35 hydrogen peroxide 4 sessions 1 session week G6 - Violet LED associated to 30 carbamide peroxide 4 sessions 1 session week G7 - hybrid technique HP Violet LED application of 35 hydrogen peroxide violet LED 4 sessions 1 sessionweek G8 - Hybrid technique CP HP Violet LED application of 30 carbamide peroxide violet LED 4 sessions 1 sessionweek The color evaluation will be performed at predetermined times before and immediately after treatment 14 days after completion of bleaching and 3 6 and 12 months after completion of bleaching and quantitatively evaluated by colorimetric tests objective and subjective and spectrophotometry In addition it will be evaluated the tooth sensitivity during and after 48 hours tooth whitening VAS Scale satisfaction with the treatment and impact on quality of life OHIP-14 questionnaire The data except for survey data of satisfaction descriptive evaluation will be subjected to statistical analysis to determine the homogeneity and normality of the sample and for comparison between treatment groups considering a 5 significance level
Detailed Description:
The objective of this clinical study is to evaluate the effect of the whitening treatment performed with the violet LED light 405-410 nm with or without a bleaching gel on the tooth color changes immediate and long-term tooth sensitivity satisfaction of participants in relation to the technique and impact on their quality of life
This study was approved by the research ethics committee of School of Dentistry of University of Sao Paulo Protocol 1981756 The experimental design is in according to CONSORT The present research will be a blind parallel and randomized study with similar allocation between the treatment groups It will be included 200 participants selected among the patients of the Special Laboratory of lasers in dentistry LELO-FOUSP After being being informed of the objectives of the study the participants will be randomly divided into a treatment group n 25
G1 - In-office bleaching performed with 35 hydrogen peroxide 4 sessions 1 sessionweek
G2 - In-office bleaching performed with 30 carbamide peroxide 4 sessions 1 sessionweek
G3 - In-office bleaching performed with Violet LED 405-410 nm 4 sessions 1 sessionweek
G4 - In-office bleaching performed with Violet LED 405-410 nm 4 sessions 2 sessionsweek
G5 - In-office bleaching performed Violet LED associated to 35 hydrogen peroxide 4 sessions 1 session week
G6 - In-office bleaching performed Violet LED associated to 30 carbamide peroxide 4 sessions 1 session week
G7 - hybrid technique HP Violet LED application of 35 hydrogen peroxide violet LED 4 sessions 1 sessionweek
G8 - Hybrid technique CP HP Violet LED application of 30 carbamide peroxide violet LED 4 sessions 1 sessionweek
The primary outcome of this study is the color alteration which will be evaluated quantitatively by colorimetric subjective and spectrophotometric objective tests Additionally will be evaluated dental sensitivity during and after treatment predetermined times patient satisfaction regarding the treatment and impact on patient quality of life questionnaire OHIP-14
The color measurement will be blind in predetermined times before the treatment immediately after the treatment 14 days after 3 months after 6 months after and 12 months after It will be performed by two methods subjectively with a color scale and objectively with a clinical spectrophotometer
The evaluation of dental sensitivity will be measured with a Visual analogue scale VAS It will be performed immediately after the treatment and 48 hours after the treatment
The patient satisfaction regarding the treatment will be measured with a questionnaire for self-evaluation of the treatment and will be applied 14 days after the end of treatment 3 months after 6 months after and 12 months after
The evaluation of quality of life of the patients will be performed with the OHIP-14 questionnaire which will be applied after the end of the treatment
This study was approved by the research ethics committee of School of Dentistry of University of Sao Paulo Protocol 1981756 The experimental design is in according to CONSORT The present research will be a blind parallel and randomized study with similar allocation between the treatment groups It will be included 200 participants selected among the patients of the Special Laboratory of lasers in dentistry LELO-FOUSP After being being informed of the objectives of the study the participants will be randomly divided into a treatment group n 25
G1 - In-office bleaching performed with 35 hydrogen peroxide 4 sessions 1 sessionweek
G2 - In-office bleaching performed with 30 carbamide peroxide 4 sessions 1 sessionweek
G3 - In-office bleaching performed with Violet LED 405-410 nm 4 sessions 1 sessionweek
G4 - In-office bleaching performed with Violet LED 405-410 nm 4 sessions 2 sessionsweek
G5 - In-office bleaching performed Violet LED associated to 35 hydrogen peroxide 4 sessions 1 session week
G6 - In-office bleaching performed Violet LED associated to 30 carbamide peroxide 4 sessions 1 session week
G7 - hybrid technique HP Violet LED application of 35 hydrogen peroxide violet LED 4 sessions 1 sessionweek
G8 - Hybrid technique CP HP Violet LED application of 30 carbamide peroxide violet LED 4 sessions 1 sessionweek
The primary outcome of this study is the color alteration which will be evaluated quantitatively by colorimetric subjective and spectrophotometric objective tests Additionally will be evaluated dental sensitivity during and after treatment predetermined times patient satisfaction regarding the treatment and impact on patient quality of life questionnaire OHIP-14
The color measurement will be blind in predetermined times before the treatment immediately after the treatment 14 days after 3 months after 6 months after and 12 months after It will be performed by two methods subjectively with a color scale and objectively with a clinical spectrophotometer
The evaluation of dental sensitivity will be measured with a Visual analogue scale VAS It will be performed immediately after the treatment and 48 hours after the treatment
The patient satisfaction regarding the treatment will be measured with a questionnaire for self-evaluation of the treatment and will be applied 14 days after the end of treatment 3 months after 6 months after and 12 months after
The evaluation of quality of life of the patients will be performed with the OHIP-14 questionnaire which will be applied after the end of the treatment
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