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
About this trial
This is an interventional treatment trial for Tooth Discoloration focused on measuring tooth bleaching, adolescent, clinical trial
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
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
NCT ID
NCT02414464
First Posted
December 9, 2014
Last Updated
May 1, 2018
Sponsor
University of Nove de Julho
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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