Ignite Creation Date:
2024-05-06 @ 3:33 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02316080
Status:
COMPLETED
Last Update Posted:
2014-12-12
First Post:
2011-09-21
Brief Title:
The Effect of Desensitizing Agents in In-home or In-office Dental Bleaching
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Evaluating Remineralizers and Desensitizers Agents in Dental Bleaching Treatment in Vitro and in Vivo Study
Status:
COMPLETED
Status Verified Date:
2014-12
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 aim of this project is to evaluate in vitro and in vivo the effect of dental bleaching agents carbamide peroxide 16 T1 and hydrogen peroxide 35 T2 together with desensitizersremineralizer agents Sensodyne dentifrice D1 experimental dentifrice with 75 of Biosilicate micro-particles D2 Odontis RX dentifrice D3 Sorriso dentifrice D4 Biosilicate micro-particles paste 11 D5 Desensebilize Nano P D6 bioglass type 45S5 paste 11 D7 GC distilled water in the experimental groups T1D1 T1D2 T1D3 T1D4 T1D5 T1D6 T1D7 T1GC e T2D1 T2D2 T2D3 T2D4 T2D5 T2D6 T2D7 T2GC In the in vitro study microhardness and roughness measurements and images using scanning electron microscopy SEM will be made on samples of bovine dental enamel and dentin 4x4x3mm n10 per group before and after the treatment with the bleaching gels T1 14 days 04 hoursday T2single session and the desensitizersremineralizer agents In the clinical study the volunteers n10 per group will be evaluated regarding dentin hypersensitivity DH using visual analogue scale before the beginning of the treatments T1 and T2 and during the next 14 days 1º 3º 7º 10 º e 14º days in which the desensitizersremineralizer agents theres no control group in the clinical experiments will be applying Data will be analysed intra and inter-group statistically
Detailed Description:
Background Tooth sensitivity TS is a common side effect of tooth bleaching The authors conducted a study to evaluate the efficiency of experimental desensitizing agents in reducing TS caused by bleaching agents
Methods To test experimental desensitizing agents in TS caused by dental bleaching the authors selected 113 participants without TS and randomly treated them with T1-16 carbamide peroxide 14 days or T2-35 hydrogen peroxide single session The period of the study was 14 days Participants in T1 and T2 used domestic-use DU or in office IO desensitizers D Control Group DU- experimental dentifrice with 75 of Biosilicate micro-particles-D1 Sensodyne dentifrice-D2 DU-Odontis RX Sensiblock dentifrice-D3 IO-Biosilicate micro-particles paste 11-D4 IO-bioglass type 45S5 paste 11 D6 IO-Desensebilize Nano P-D6 On days 1 3 7 10 and 14 the authors received the participants to apply IO desensitizers and to record TS with Visual Analogue Scale VAS Data was analyzed with two-way ANOVA considering time and desensitizing as factors and post-hoc Bonferroni test α005
Results The use of experimental desensitizing agents G2 and G5 did not cause significantly difference in TS comparing to baseline TS was not significantly different when G2 was used after 16 carbamide peroxide and G5 after 35 hydrogen peroxide application Self-perception TS values were significantly p0001 higher than recorded VAS
Conclusions Experimental desensitizing agents containing Biosilicate can prevent TS caused by bleaching agents in dentifrice form when associated to 16 carbamide peroxide and in paste when 35 hydrogen peroxide is used
Methods To test experimental desensitizing agents in TS caused by dental bleaching the authors selected 113 participants without TS and randomly treated them with T1-16 carbamide peroxide 14 days or T2-35 hydrogen peroxide single session The period of the study was 14 days Participants in T1 and T2 used domestic-use DU or in office IO desensitizers D Control Group DU- experimental dentifrice with 75 of Biosilicate micro-particles-D1 Sensodyne dentifrice-D2 DU-Odontis RX Sensiblock dentifrice-D3 IO-Biosilicate micro-particles paste 11-D4 IO-bioglass type 45S5 paste 11 D6 IO-Desensebilize Nano P-D6 On days 1 3 7 10 and 14 the authors received the participants to apply IO desensitizers and to record TS with Visual Analogue Scale VAS Data was analyzed with two-way ANOVA considering time and desensitizing as factors and post-hoc Bonferroni test α005
Results The use of experimental desensitizing agents G2 and G5 did not cause significantly difference in TS comparing to baseline TS was not significantly different when G2 was used after 16 carbamide peroxide and G5 after 35 hydrogen peroxide application Self-perception TS values were significantly p0001 higher than recorded VAS
Conclusions Experimental desensitizing agents containing Biosilicate can prevent TS caused by bleaching agents in dentifrice form when associated to 16 carbamide peroxide and in paste when 35 hydrogen peroxide is used
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