Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-25 @ 5:33 PM
Study NCT ID:
NCT05789004
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-04
First Post:
2023-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Tooth Bleaching With 35% and 6% Hydrogen Peroxide in Primary Dentition
Sponsor:
University of Nove de Julho
Organization:
Study Overview
Official Title:
Efficacy of Tooth Bleaching With 35% and 6% Hydrogen Peroxide in Primary Dentition: Study Protocol for a Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
The aesthetics of dental elements generates great psychological and social impacts, both in the deciduous and permanent dentition. One of the techniques widely used to visually improve the appearance of teeth is bleaching. Bleaching can be performed both at home and in a dental office. In office whitening, the technique used consists of applying the whitening gel to the dental surfaces in concentrations ranging from 25% to 50% of hydrogen peroxide. However, recent studies show that low and medium concentration bleaching agents based on hydrogen peroxide have been effective and present a lower risk of sensitivity to the patient. In view of the above, this study aims to carry out a controlled and randomized clinical trial to compare the effectiveness of dental bleaching in deciduous teeth with hydrogen peroxide at concentrations of 35% and 6%. For this, 38 patients aged 03 to 06 years will be selected, allocated in 2 groups (G1 - Hydrogen Peroxide 35%, n=19 and G2- Hydrogen Peroxide 6%, n=19). Bleaching will be carried out in up to three sessions, with an interval of 7 days between them and the evaluation of color and tooth sensitivity will be carried out 48 hours after each bleaching session. The color assessment will be measured using a digital spectrometer and tooth sensitivity using the Pain Level Scale (Wong-Baker Faces®). Descriptive statistical analysis will be carried out, containing the mean and standard deviation in the calculation and normality and homogeneity tests will be carried out, for subsequent adequate statistical analysis. As a result, it is expected that there is no significant difference between the groups in terms of color variation and that the low-concentration bleaching group has the lowest sensitivity index.
Detailed Description:
None
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?: