Ignite Creation Date:
2024-05-06 @ 9:34 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03019224
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2016-12-19
Brief Title:
Effects of Desensitizing Dentifrices on the Reduction of Pain Sensitivity Caused by In-office Dental Whitening
Sponsor:
University of Campinas Brazil
Organization:
University of Campinas Brazil
Study Overview
Official Title:
Effects of Desensitizing Dentifrices on the Reduction of Pain Sensitivity Caused by In-office Dental Whitening Double Blind Controlled Clinical Study
Status:
COMPLETED
Status Verified Date:
2016-01
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:
Introduction The pain sensitivity associated with whitening is the main problem reported by patients during dental whitening and the use of desensitizing dentifrices is an alternative for the treatment of sensitivity
Objective To evaluate clinically the influence of desensitizing dentifrices applied through a plastic tray reducing the pain sensitivity and color variation caused by the technique of in-office dental whitening through a controlled double-blind clinical study
Methods A longitudinal prospective study was conducted with 48 individuals 18 years and 30 years of age without gender distinction who underwent in-office dental whitening using 35 hydrogen peroxide Whiteness HP FGM Joinville SC Brazil in three clinical sessions with a one-week interval between them The volunteers used in the night for each bleaching session a plastic tray for 4 hours containing one of the dentifrices related to the experimental groups Group 1 Control - Sucralose S Biotype - Manipulation pharmacy Group 2 Active control - Sodium fluoride FS with 1450ppm of fluorine Close up triple Unilever Group 3 - Arginine calcium carbonate ACC and sodium monofluorophosphate with 1450 ppm fluorine Colgate sensitive pro-relief Colgate-Palmolive Group 4 - 5 potassium nitrate NP and sodium fluoride with 1450 ppm fluorine Sensodyne pro-enamel GlaxoSmithKline The evaluation of the sensitivity associated with the times of use of the plastic tray in the first session S1 sensitivity before the tray S2 sensitivity after the tray in the second session S3 sensitivity before the tray S4 in the third session S5 sensitivity before the tray S6 sensitivity after the tray used the analog numerical scale with scores from 0 to 10 and for the color evaluation the spectrophotometer Easyshade Vident Brea CA Obtaining the data that were used in the CIELab system The data were submitted to the multivariate analysis of variance MANOVA with repeated measurements and Lambda Wilks test with a 5 probability level to differentiate the groups In addition the factorial variance analysis ANOVA in one criterion was applied Values of p 005 were considered statistically significant
Objective To evaluate clinically the influence of desensitizing dentifrices applied through a plastic tray reducing the pain sensitivity and color variation caused by the technique of in-office dental whitening through a controlled double-blind clinical study
Methods A longitudinal prospective study was conducted with 48 individuals 18 years and 30 years of age without gender distinction who underwent in-office dental whitening using 35 hydrogen peroxide Whiteness HP FGM Joinville SC Brazil in three clinical sessions with a one-week interval between them The volunteers used in the night for each bleaching session a plastic tray for 4 hours containing one of the dentifrices related to the experimental groups Group 1 Control - Sucralose S Biotype - Manipulation pharmacy Group 2 Active control - Sodium fluoride FS with 1450ppm of fluorine Close up triple Unilever Group 3 - Arginine calcium carbonate ACC and sodium monofluorophosphate with 1450 ppm fluorine Colgate sensitive pro-relief Colgate-Palmolive Group 4 - 5 potassium nitrate NP and sodium fluoride with 1450 ppm fluorine Sensodyne pro-enamel GlaxoSmithKline The evaluation of the sensitivity associated with the times of use of the plastic tray in the first session S1 sensitivity before the tray S2 sensitivity after the tray in the second session S3 sensitivity before the tray S4 in the third session S5 sensitivity before the tray S6 sensitivity after the tray used the analog numerical scale with scores from 0 to 10 and for the color evaluation the spectrophotometer Easyshade Vident Brea CA Obtaining the data that were used in the CIELab system The data were submitted to the multivariate analysis of variance MANOVA with repeated measurements and Lambda Wilks test with a 5 probability level to differentiate the groups In addition the factorial variance analysis ANOVA in one criterion was applied Values of p 005 were considered statistically significant
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None