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Tooth Bleaching for Young Patients Using a Hydrogen Peroxide-based Gel

Primary Purpose

Tooth Discoloration

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
35% hydrogen peroxide
35% hydrogen peroxide
20% hydrogen peroxide
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Discoloration focused on measuring tooth bleaching, adolescent, clinical trial

Eligibility Criteria

11 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Individuals aged 11 to 24 years with a diagnosis of tooth discoloration and a signed statement of informed consent.

Exclusion Criteria:

  • Individuals with dentofacial anomalies, those without the permanent dentition complete to the second molars, those in orthodontic or orthopedic treatment of the jaws, those who took medications that could alter tooth color and those who had previously been submitted to tooth bleaching

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    35% hydrogen peroxide

    35% hydrogen peroxide with calcium

    20% hydrogen peroxide with calcium

    Arm Description

    Volunteers of this group will receive a gel with 35% hydrogen peroxide - Whiteness HP 35% for whitening treatment.

    Volunteers of this group will receive a gel with 35% hydrogen peroxide with calcium - Whiteness HP Blue Calcium 35% for whitening treatment.

    Volunteers of this group will receive a gel with 35% hydrogen peroxide with calcium - Whiteness HP Blue Calcium 20% for whitening treatment.

    Outcomes

    Primary Outcome Measures

    Discoloration
    the initial tooth color was determined with the aid of the classic Vita® scale. Tooth color was recorded 48 hours after each session to determine the difference in tone before and after the procedures. It will be carried out in all groups at the following times: pre-treatment period, 48 hours following each session, after six months, after 12 months, after 18 months.

    Secondary Outcome Measures

    Dental sensitivity
    The visual analog scale was used for the subjective measure of sensitivity during and after the procedures.

    Full Information

    First Posted
    December 9, 2014
    Last Updated
    May 1, 2018
    Sponsor
    University of Nove de Julho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02414464
    Brief Title
    Tooth Bleaching for Young Patients Using a Hydrogen Peroxide-based Gel
    Official Title
    In-Office Tooth Bleaching for Young Patients Using a Hydrogen Peroxide-based Gel: a Randomized, Controlled, Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2013 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of the present study was to evaluate colorimetric changes and tooth sensitivity in young patients submitted to tooth bleaching with 20% and 35% hydrogen peroxide.
    Detailed Description
    A randomized, controlled, clinical trial was conducted with 53 patients aged 11 to 24 years who were allocated to groups based on the use of the following commercial products: Whiteness HP - FGM® (35% hydrogen peroxide); Whiteness HP Blue Calcium - FGM® (35% hydrogen peroxide); and Whiteness HP Blue Calcium - FGM® (20% hydrogen peroxide). After the bleaching procedure, the visual analog scale was used to measure tooth sensitivity and the classic Vita® scale was used to determine changes in tooth color. Statistical analysis involved the Friedman, Kruskal-Wallis and Student-Newman-Keuls tests, with p-value ≤ 0.05 or ≤ 0.0001 considered indicative of statistical significance.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Discoloration
    Keywords
    tooth bleaching, adolescent, clinical trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    53 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    35% hydrogen peroxide
    Arm Type
    Experimental
    Arm Description
    Volunteers of this group will receive a gel with 35% hydrogen peroxide - Whiteness HP 35% for whitening treatment.
    Arm Title
    35% hydrogen peroxide with calcium
    Arm Type
    Experimental
    Arm Description
    Volunteers of this group will receive a gel with 35% hydrogen peroxide with calcium - Whiteness HP Blue Calcium 35% for whitening treatment.
    Arm Title
    20% hydrogen peroxide with calcium
    Arm Type
    Experimental
    Arm Description
    Volunteers of this group will receive a gel with 35% hydrogen peroxide with calcium - Whiteness HP Blue Calcium 20% for whitening treatment.
    Intervention Type
    Other
    Intervention Name(s)
    35% hydrogen peroxide
    Other Intervention Name(s)
    Whiteness HP 35%
    Intervention Description
    Prophylaxis was performed with a jet of sodium bicarbonate to remove extrinsic pigments and plaque. Each patient underwent two bleaching sessions. A lip retractor (Arc Flex, FGM®) was placed. Cotton roles or gauze compresses were used to achieve relative isolation. A dental dam (Top Dam, FGM®) was placed over the free marginal gingival tissue and the inter-tooth papillae of teeth 14 to 24 in each session. The Whiteness HP 35% gel was applied to the vestibular faces of these teeth. In the present study, the Whiteness HP 35% gel was applied without an external auxiliary source. As this is not a self-catalyzed system, the gel was removed after each 15-minute application and reapplied two more times, totaling 45 minutes of contact with the teeth.
    Intervention Type
    Other
    Intervention Name(s)
    35% hydrogen peroxide
    Other Intervention Name(s)
    Whiteness HP Blue Calcium 35%
    Intervention Description
    Prophylaxis was performed with a jet of sodium bicarbonate to remove extrinsic pigments and plaque. Each patient underwent two bleaching sessions. A lip retractor (Arc Flex, FGM®) was placed. Cotton roles or gauze compresses were used to achieve relative isolation. A dental dam (Top Dam, FGM®) was placed over the free marginal gingival tissue and the inter-tooth papillae of teeth 14 to 24 in each session. The Whiteness HP Blue Calcium 35% gel was applied to the vestibular faces of these teeth for 40 minutes in each session.
    Intervention Type
    Other
    Intervention Name(s)
    20% hydrogen peroxide
    Other Intervention Name(s)
    Whiteness HP Blue Calcium 20%
    Intervention Description
    Prophylaxis was performed with a jet of sodium bicarbonate to remove extrinsic pigments and plaque. Each patient underwent two bleaching sessions. A lip retractor (Arc Flex, FGM®) was placed. Cotton roles or gauze compresses were used to achieve relative isolation. A dental dam (Top Dam, FGM®) was placed over the free marginal gingival tissue and the inter-tooth papillae of teeth 14 to 24 in each session. The Whiteness HP Blue Calcium 20% gel was applied to the vestibular faces of these teeth 50 minutes in each session.
    Primary Outcome Measure Information:
    Title
    Discoloration
    Description
    the initial tooth color was determined with the aid of the classic Vita® scale. Tooth color was recorded 48 hours after each session to determine the difference in tone before and after the procedures. It will be carried out in all groups at the following times: pre-treatment period, 48 hours following each session, after six months, after 12 months, after 18 months.
    Time Frame
    Change of teeth color after 48 hours, after 6 months, after 12 months, after 18 months
    Secondary Outcome Measure Information:
    Title
    Dental sensitivity
    Description
    The visual analog scale was used for the subjective measure of sensitivity during and after the procedures.
    Time Frame
    Sensivity alteration up to 48 hours after the procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    24 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Individuals aged 11 to 24 years with a diagnosis of tooth discoloration and a signed statement of informed consent. Exclusion Criteria: Individuals with dentofacial anomalies, those without the permanent dentition complete to the second molars, those in orthodontic or orthopedic treatment of the jaws, those who took medications that could alter tooth color and those who had previously been submitted to tooth bleaching
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sandra K Bussadori, Doctor
    Organizational Affiliation
    University of Nove de Julho
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Tooth Bleaching for Young Patients Using a Hydrogen Peroxide-based Gel

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