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

Primary Purpose

Sensitivity, Tooth

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Tooth Bleaching with Whiteness HP Automixx 35%
Tooth Bleaching with Whiteness HP Automixx 6%
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensitivity, Tooth

Eligibility Criteria

3 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Hydrogen Peroxide 35%

    Hydrogen Peroxide 6%

    Arm Description

    In the participants of this group, the tooth whitening process will be performed with 35% hydrogen peroxide.

    In the participants of this group, the tooth whitening process will be performed with 6% hydrogen peroxide.

    Outcomes

    Primary Outcome Measures

    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).
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 16, 2023
    Last Updated
    August 9, 2023
    Sponsor
    University of Nove de Julho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05789004
    Brief Title
    Efficacy of Tooth Bleaching With 35% and 6% Hydrogen Peroxide in Primary Dentition
    Official Title
    Efficacy of Tooth Bleaching With 35% and 6% Hydrogen Peroxide in Primary Dentition: Study Protocol for a Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    February 20, 2024 (Anticipated)
    Study Completion Date
    October 20, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Nove de Julho

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sensitivity, Tooth

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    38 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hydrogen Peroxide 35%
    Arm Type
    Experimental
    Arm Description
    In the participants of this group, the tooth whitening process will be performed with 35% hydrogen peroxide.
    Arm Title
    Hydrogen Peroxide 6%
    Arm Type
    Experimental
    Arm Description
    In the participants of this group, the tooth whitening process will be performed with 6% hydrogen peroxide.
    Intervention Type
    Procedure
    Intervention Name(s)
    Tooth Bleaching with Whiteness HP Automixx 35%
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Tooth Bleaching with Whiteness HP Automixx 6%
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Changes in tooth color
    Description
    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).
    Time Frame
    Baseline and 48 hours after each bleaching session.
    Title
    Changes in tooth sensitivity
    Description
    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.
    Time Frame
    Baseline and 48 hours after each bleaching session.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.

    12. IPD Sharing Statement

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

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