Efficacy of Tooth Bleaching With 35% and 6% Hydrogen Peroxide in Primary Dentition
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tooth Bleaching with Whiteness HP Automixx 35%, Tooth Bleaching with Whiteness HP Automixx 6%.
- Who it may be relevant to
- Registry conditions: Sensitivity, Tooth. Basic parameters: 3 years — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Tooth Bleaching With 35% and 6% Hydrogen Peroxide in Primary Dentition: Study Protocol for a Randomized Controlled Clinical Trial
Overview
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.
Interventions
- Procedure Tooth Bleaching with Whiteness HP Automixx 35%
* Clinical examination and taking the initial shade of the tooth with Vita Easyshade®; * Sensitivity/pain recording using the Pain Level Scale (Wong-Baker Faces®); * Prophylaxis with a Robson brush and prophylactic paste; * Application of lip balm on the patient's lips; * Placement of the labial retractor; * Application of the gingival barrier; * Application of Whiteness HP Automixx 35% whitening gel; * In the session, a single application of the gel will be carried out and where it will remain - Procedure Tooth Bleaching with Whiteness HP Automixx 6%
* Clinical examination and taking the initial shade of the tooth with Vita Easyshade®; * Sensitivity/pain recording using the Pain Level Scale (Wong-Baker Faces®); * Prophylaxis with a Robson brush and prophylactic paste; * Application of lip balm on the patient's lips; * Placement of the labial retractor; * Application of the gingival barrier; * Application of Whiteness HP Automixx 6% whitening gel; * In the session, a single application of the gel will be carried out and where it will remain o
Primary outcome measures
- Changes in tooth color [Time frame: Baseline and 48 hours after each bleaching session.]
- Changes in tooth sensitivity [Time frame: Baseline and 48 hours after each bleaching session.]
Eligibility criteria
Inclusion criteria
- Age range from 03 to 06 years old;
- Vital or non-vital teeth (already endodontically treated) with severe to moderate discoloration;
- No active carious lesions;
- No lesions in the oral cavity;
- No report of previous tooth sensitivity.
Exclusion criteria
\- Patients who during anamnesis report allergies to dyes or latex, who withdraw from participating in the study, as well as those who do not attend the callbacks, will be excluded.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05789004 · DeciduousBleaching