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

Sensitivity, Tooth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05789004
• Other study ID #: DeciduousBleaching
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: December 1, 2023
• Est. completion date: October 20, 2024

Study information

• Verified date: August 2023
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: October 20, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dentin Sensitivity
• Sensitivity, Tooth

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.