Efficacy of Tooth Bleaching With 35% and 6% Hydrogen Peroxide in Primary Dentition

Efficacy of Tooth Bleaching With 35% and 6% Hydrogen Peroxide in Primary Dentition: Study Protocol for a Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sensitivity, Tooth
• Intervention / Treatment: Procedure: Tooth Bleaching with Whiteness HP Automixx 35%; Procedure: Tooth Bleaching with Whiteness HP Automixx 6%

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrogen Peroxide 35%; In the participants of this group, the tooth whitening process will be performed with 35% hydrogen peroxide.	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 on the surface of the tooth for 15 min;; The gel must be removed from the teeth with a sucker and the teeth cleaned with gauze;; Sensitivity/pain recording using the Pain Level Scale (Wong-Baker Faces®);; The second bleaching session will be carried out 7 days after the first one and, if necessary, a third session can be carried out 7 days after the second one.
Experimental: Hydrogen Peroxide 6%; In the participants of this group, the tooth whitening process will be performed with 6% hydrogen peroxide.	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 on the surface of the tooth for 15 min;; The gel must be removed from the teeth with a sucker and the teeth cleaned with gauze;; Sensitivity/pain recording using the Pain Level Scale (Wong-Baker Faces®);; The second bleaching session will be carried out 7 days after the first one and, if necessary, a third session can be carried out 7 days after the second one.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in tooth color	The Vita Easyshade® digital spectrometer (VITA Zahnfabrik H. Rauter GmbH & Co. KG, Germany) will be used for evaluation. The upper left canine will be used as a color reference because it is the most saturated tooth in the arch (greater dentin mass and greater amount of intrinsic pigments).	Baseline and 48 hours after each bleaching session.
Changes in tooth sensitivity	It will be explained to the participant that each face drawn in a figure represents a person who has no pain, or some, or a lot of pain. Face 0 doesn't hurt at all. Face 2 hurts a little. Face 4 hurts a little more. Face 6 hurts a lot. Face 8 hurts the most. Face 10 hurts as much as you can imagine, although you don't have to be crying to have this worst pain. The participant will choose the face that best portrays the pain they are experiencing.	Baseline and 48 hours after each bleaching session.

Collaborators and Investigators

• Sponsor: University of Nove de Julho

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): August 20, 2025
• Study Completion (Estimated): March 20, 2026

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: March 16, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dentin Sensitivity
• Other Study ID Numbers: DeciduousBleaching

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No