Ignite Creation Date:
2024-05-06 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05298059
Status:
UNKNOWN
Last Update Posted:
2022-04-21
First Post:
2022-03-17
Brief Title:
The Association of CPP-ACPF Associated With LASER in the Treatment of Tooth Sensitivity After at Home Bleaching
Sponsor:
Universidade Federal do Para
Organization:
Universidade Federal do Para
Study Overview
Official Title:
Effectiveness of Association of Casein Phosphopeptides-fluoridated Amorphous Calcium Phosphate Associated With Photobiomodulation in the Treatment of Tooth Sensitivity After Home Bleaching A Randomized Split-mouth Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
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:
Tooth whitening is a procedure that has been increasingly requested by patients around the world whether at home or in office bleaching Tooth sensitivity is the main side effect of bleaching It have a great power to interfere negatively in the quality of life of those affected According to the literature about 51 of people who had at-home bleaching developed postoperative sensitivity
The objective of this clinical randomized double-blind study is to evaluate the effectiveness of the association of casein phosphopeptides-fluoridated amorphous calcium phosphate with photobiomodulation in the treatment of tooth sensitivity after home bleaching with 22 carbamide peroxide and also evaluate the effectiveness of at home bleaching through color analysis
For develop this study 50 patients will be selected with no previous history of sensitivity aged between 18 and 30 years They will be divided into four treatment groups PLACEBO group CPP-ACPF group LASER group LASERCPP-ACPF group
Home bleaching treatment will use 22 carbamide peroxide Patients should use two hours a day for 21 days The desensitizing treatments will be applied in four moments according to the group of each patient before starting the bleaching treatment after one week of the bleaching treatment after two weeks of whitening treatment and after three weeks of whitening treatment
Sensitivity will be assessed using a visual analogue scale VAS where patients should daily mark their pain level from 0 to 10 on each side of the arcade After the 21 days of treatment they will receive a new VAS to evaluate if was any sensitivity will occur during 30 days after the bleaching treatment
In parallel with bleaching treatment and sensitivity treatment the color analysis of teeth 13 11 21 and 23 will be performed with the Vita Easyshade Advance 40 spectrophotometer to monitor the bleaching performance in each week The first one will occur before starting the bleaching treatment baseline and a new measurement will be performed every week together with the application of treatments for sensitivity
The collected data will be tabulated in an Excel Microsoft Windows 2010 spreadsheet and analyzed in the Jamovi 1623 The Jamovi Project 2020 software For inter- and intra-group analysis of sensitivity values the Repeated Measures statistical test will probably be used For all statistical analyses a significance level of 5 will be adopted
The objective of this clinical randomized double-blind study is to evaluate the effectiveness of the association of casein phosphopeptides-fluoridated amorphous calcium phosphate with photobiomodulation in the treatment of tooth sensitivity after home bleaching with 22 carbamide peroxide and also evaluate the effectiveness of at home bleaching through color analysis
For develop this study 50 patients will be selected with no previous history of sensitivity aged between 18 and 30 years They will be divided into four treatment groups PLACEBO group CPP-ACPF group LASER group LASERCPP-ACPF group
Home bleaching treatment will use 22 carbamide peroxide Patients should use two hours a day for 21 days The desensitizing treatments will be applied in four moments according to the group of each patient before starting the bleaching treatment after one week of the bleaching treatment after two weeks of whitening treatment and after three weeks of whitening treatment
Sensitivity will be assessed using a visual analogue scale VAS where patients should daily mark their pain level from 0 to 10 on each side of the arcade After the 21 days of treatment they will receive a new VAS to evaluate if was any sensitivity will occur during 30 days after the bleaching treatment
In parallel with bleaching treatment and sensitivity treatment the color analysis of teeth 13 11 21 and 23 will be performed with the Vita Easyshade Advance 40 spectrophotometer to monitor the bleaching performance in each week The first one will occur before starting the bleaching treatment baseline and a new measurement will be performed every week together with the application of treatments for sensitivity
The collected data will be tabulated in an Excel Microsoft Windows 2010 spreadsheet and analyzed in the Jamovi 1623 The Jamovi Project 2020 software For inter- and intra-group analysis of sensitivity values the Repeated Measures statistical test will probably be used For all statistical analyses a significance level of 5 will be adopted
Detailed Description:
Tooth whitening is a procedure that has been increasingly requested by patients around the world whether at home or in office bleaching Tooth sensitivity is the main side effect of bleaching It have a great power to interfere negatively in the quality of life of those affected According to the literature about 51 of people who had at-home bleaching developed postoperative sensitivity
The objective of this clinical randomized double-blind study is to evaluate the effectiveness of the association of casein phosphopeptides-fluoridated amorphous calcium phosphate with photobiomodulation in the treatment of tooth sensitivity after home bleaching with 22 carbamide peroxide and also evaluate the effectiveness of at home bleaching through color analysis
Fifty patients will be selected who will be divided into four treatment groups PLACEBO group will receive a LASER simulation and a manipulated paste without active ingredient to simulate the CPP-ACPF paste CPP-ACPF group will receive the CPP-ACPF folder and a LASER simulation LASER group will receive the LASER and a manipulated paste without active ingredient to simulate the CPP-ACPF paste LASERCPP-ACPF group will receive the LASER and the CPP-ACPF folder As it is a split-mouth study each patient will receive two different types of treatment one on each side of the arches thus the sample size of each group will be 25 patients n25
The treatment with the CPP-ACPF paste MI paste plus will be carried out in the CPP-ACPF and LASERCPP-ACPF groups at the following times before the bleaching treatment T0 after one week of bleaching T1 after two weeks of bleaching T2 after three weeks of bleaching T3 The application will be made on the buccal surfaces of the teeth up to the second premolars with the aid of a microbrush applicator Microbrush 3M Espe for five minutes Afterwards patients will be instructed to spit out the excess and avoid ingesting anything for 30 minutes In the PLACEBO group this clinical protocol will be performed exactly but using the paste without active ingredient
The LASER and CPP-ACPFFBM groups will receive the application of LASER Therapy EC DMC São Carlos SP Brazil using the infrared light spectrum with a wavelength of 808 nm with its active medium of Arsento Gallium and Aluminum AsGaAl at three points one in the center of the crown of the tooth another in the center of the cervical region and the last one in the incisal region with the light beam directed apically from all teeth to the second premolar of each hemi -upper and lower arch The energy used was 1 Joule per point for 10 seconds
While the PLACEBO and CPP-ACPF groups received a LASER simulation The sounds emitted by the laser during its use will be simulated by a mobile application
All study participants will receive a tube of bleaching agent Whiteness Simple 22 FGM Joinville Brazil and will be instructed to apply a drop of the product on the vestibular surface of each tooth on the whitening tray up to the second premolars and use for two uninterrupted hours for 21 days
Sensitivity will be assessed using a visual analogue scale VAS where patients should daily mark their pain level from 0 to 10 on each side of the arcade After the 21 days of treatment they will receive a new VAS to evaluate if was any sensitivity will occur during 30 days after the bleaching treatment
In parallel with bleaching treatment and sensitivity treatment the color analysis of teeth 13 11 21 and 23 will be performed with the Vita Easyshade Advance 40 spectrophotometer to monitor the bleaching performance in each week The first one will occur before starting the bleaching treatment baseline and a new measurement will be performed every week together with the application of treatments for sensitivity
The collected data will be tabulated in an Excel Microsoft Windows 2010 spreadsheet and analyzed in the Jamovi 1623 The Jamovi Project 2020 software For inter- and intra-group analysis of sensitivity values the Repeated Measures statistical test will probably be used For all statistical analyses a significance level of 5 will be adopted
The objective of this clinical randomized double-blind study is to evaluate the effectiveness of the association of casein phosphopeptides-fluoridated amorphous calcium phosphate with photobiomodulation in the treatment of tooth sensitivity after home bleaching with 22 carbamide peroxide and also evaluate the effectiveness of at home bleaching through color analysis
Fifty patients will be selected who will be divided into four treatment groups PLACEBO group will receive a LASER simulation and a manipulated paste without active ingredient to simulate the CPP-ACPF paste CPP-ACPF group will receive the CPP-ACPF folder and a LASER simulation LASER group will receive the LASER and a manipulated paste without active ingredient to simulate the CPP-ACPF paste LASERCPP-ACPF group will receive the LASER and the CPP-ACPF folder As it is a split-mouth study each patient will receive two different types of treatment one on each side of the arches thus the sample size of each group will be 25 patients n25
The treatment with the CPP-ACPF paste MI paste plus will be carried out in the CPP-ACPF and LASERCPP-ACPF groups at the following times before the bleaching treatment T0 after one week of bleaching T1 after two weeks of bleaching T2 after three weeks of bleaching T3 The application will be made on the buccal surfaces of the teeth up to the second premolars with the aid of a microbrush applicator Microbrush 3M Espe for five minutes Afterwards patients will be instructed to spit out the excess and avoid ingesting anything for 30 minutes In the PLACEBO group this clinical protocol will be performed exactly but using the paste without active ingredient
The LASER and CPP-ACPFFBM groups will receive the application of LASER Therapy EC DMC São Carlos SP Brazil using the infrared light spectrum with a wavelength of 808 nm with its active medium of Arsento Gallium and Aluminum AsGaAl at three points one in the center of the crown of the tooth another in the center of the cervical region and the last one in the incisal region with the light beam directed apically from all teeth to the second premolar of each hemi -upper and lower arch The energy used was 1 Joule per point for 10 seconds
While the PLACEBO and CPP-ACPF groups received a LASER simulation The sounds emitted by the laser during its use will be simulated by a mobile application
All study participants will receive a tube of bleaching agent Whiteness Simple 22 FGM Joinville Brazil and will be instructed to apply a drop of the product on the vestibular surface of each tooth on the whitening tray up to the second premolars and use for two uninterrupted hours for 21 days
Sensitivity will be assessed using a visual analogue scale VAS where patients should daily mark their pain level from 0 to 10 on each side of the arcade After the 21 days of treatment they will receive a new VAS to evaluate if was any sensitivity will occur during 30 days after the bleaching treatment
In parallel with bleaching treatment and sensitivity treatment the color analysis of teeth 13 11 21 and 23 will be performed with the Vita Easyshade Advance 40 spectrophotometer to monitor the bleaching performance in each week The first one will occur before starting the bleaching treatment baseline and a new measurement will be performed every week together with the application of treatments for sensitivity
The collected data will be tabulated in an Excel Microsoft Windows 2010 spreadsheet and analyzed in the Jamovi 1623 The Jamovi Project 2020 software For inter- and intra-group analysis of sensitivity values the Repeated Measures statistical test will probably be used For all statistical analyses a significance level of 5 will be adopted
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