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Combination of Dental Bleaching Techniques, Randomized Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02682329
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : February 18, 2016
Sponsor:
Information provided by (Responsible Party):
Leandro Feliz, Universidad Iberoamericana

Brief Summary:
To determine the effectiveness of combining different concentrations of hydrogen peroxide and carbamide used during tooth bleaching.

Condition or disease Intervention/treatment Phase
Tooth Stain Other: Hydrogen Peroxide and Carbamide Peroxide Other: Hydrogen Peroxide and Hydrogen Peroxide Phase 4

Detailed Description:

120 patiens over 18 years old.

Design:

Hydrogen peroxide (HP) Carbamide Peroxide (CP)

Group 1: CP 10% + HP 40% Group 2: CP 15% + HP 40% Group 3: CP 20% + HP 40% Group 4: HP 10% + HP 40%

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Combination of Dental Bleaching Techniques, Randomized Clinical Trial
Study Start Date : February 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CP 10% + HP 40%
Carbamide Peroxide 10% + Hydrogen Peroxide 40% were administered to each patient on this group. CP at home and HP at office
Other: Hydrogen Peroxide and Carbamide Peroxide
Carbamide Peroxide + Hydrogen Peroxide were administered to each patient on this group. HP 10% at home and HP 40% at office

Active Comparator: CP 15% + HP 40%
Carbamide Peroxide 15% + Hydrogen Peroxide 40% were administered to each patient on this group.CP at home and HP at office
Other: Hydrogen Peroxide and Carbamide Peroxide
Carbamide Peroxide + Hydrogen Peroxide were administered to each patient on this group. HP 10% at home and HP 40% at office

Active Comparator: CP 20% + HP 40%
Carbamide Peroxide 20% + Hydrogen Peroxide 40% were administered to each patient on this group.CP at home and HP at office
Other: Hydrogen Peroxide and Carbamide Peroxide
Carbamide Peroxide + Hydrogen Peroxide were administered to each patient on this group. HP 10% at home and HP 40% at office

Active Comparator: HP 10% + HP 40%
Hydrogen Peroxide 10% + Hydrogen Peroxide 40% were administered to each patient on this group. HP at Home and HP at office
Other: Hydrogen Peroxide and Hydrogen Peroxide
Hydrogen Peroxide + Hydrogen Peroxide were administered to each patient on this group. HP at home and HP at office




Primary Outcome Measures :
  1. Change in color after the intervention [ Time Frame: Two weeks ]
    The color was taken with conventional hade guide VITA by human observation, with the color range from A to D, each color range with 5 classifications. (Ej. A1, A2, A3, A4, A5)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 - 45 years old
  • Student, teacher or administrative personnel at UNIBE.

Exclusion Criteria:

  • Dental Hypersensitivity
  • Periodontal disease
  • Active caries lesions
  • Allergy to latex
  • Orthodontic treatment
Publications of Results:
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Responsible Party: Leandro Feliz, DDS, MEd, Universidad Iberoamericana
ClinicalTrials.gov Identifier: NCT02682329    
Other Study ID Numbers: Dental Bleaching Techniques
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: February 18, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Leandro Feliz, Universidad Iberoamericana:
Peroxide
Additional relevant MeSH terms:
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Tooth Discoloration
Tooth Diseases
Stomatognathic Diseases
Hydrogen Peroxide
Carbamide Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents