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Efectiveness of a Brief Protocol by a Low (6%) Concentration Gel Peroxide Hydrogen of Teeth Bleaching (Brief6%)

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ClinicalTrials.gov Identifier: NCT02603354
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : November 11, 2015
Sponsor:
Information provided by (Responsible Party):
Eduardo Fernandez, University of Chile

Brief Summary:
The purpose of this clinical study was to evaluate, the effectiveness and sensitivity post-treatment of a 6% hydrogen peroxide with nitrogen-doped titanium dioxide light activated bleaching agent, the impact of shorter interval times on tooth sensitivity and to compare the efficacy with 2 different application protocols. This is a clinical randomized double-blind split-mouth study. 31 patients were treated with: one upper hemi arcade with one application of 36 minutes and the other hemi arcade with 3 applications of 12 minutes each with a 6% hydrogen peroxide. Two sessions were appointed with 48h of intervals between them. Tooth colour was registered by VITA Classical amd VITA Bleach guide by two blinded assessors in the beginning, immediately after each session. Tooth colour variation and sensitivity were compared between both application protocols

Condition or disease Intervention/treatment Phase
Tooth Discoloration Drug: peroxide gel tooth bleaching 6% Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efectiveness of a Brief Protocol by a Low (6%) Concentration Gel Peroxide Hydrogen of Teeth Bleaching
Study Start Date : March 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Active Comparator: 3x12 m peroxide gel tooth bleaching 6%
bleaching with 6% hydrogen peroxide 3 times of 12 minutes session for in office bleaching teeth
Drug: peroxide gel tooth bleaching 6%
gel of hygrogen peroxide for teeth bleaching in a low concentration (6%)
Other Name: bleaching gel

Experimental: 1-36 m peroxide gel tooth bleaching 6%
bleaching with 6% hydrogen peroxide 1 time of 36 minutes session for in office bleaching teeth
Drug: peroxide gel tooth bleaching 6%
gel of hygrogen peroxide for teeth bleaching in a low concentration (6%)
Other Name: bleaching gel




Primary Outcome Measures :
  1. Efectiveness by color difference ( using the spectrophotometer Vita Easy Shade) [ Time Frame: 1 month ]
    The shade was determined using the obtained parameters L*, a*, and b* by Spectrophotometer . The color alteration after each session was given by the differences between the values obtained at the session and the baseline (∆E). ∆E was calculated using the following formula: ΔE = [(ΔL*)2 + (Δa*)2 + (Δb*)2]1/2 .



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy patients with Anterior teeth without restorations, previous bleaching procedures, cervical lesions, or dental pain

Exclusion Criteria:

  • Pregnant or lactating,
  • Had moderate or severe fluorosis,
  • Tetracycline stains,
  • Orthodontic treatment,
  • Periodontal disease,
  • Orofacial tumors,
  • Trauma,
  • Tooth malformation,
  • Were taking analgesic, anti-inflammatory, or antibiotic drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603354


Locations
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Chile
Eduardo Fernandez
Santiago, N/A = Not Applicable, Chile, 7500505
Sponsors and Collaborators
University of Chile
Investigators
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Study Director: Eduardo Fernandez, PhD University of Chile
Publications:
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Responsible Party: Eduardo Fernandez, Prof. Dr. Eduardo Fernández, University of Chile
ClinicalTrials.gov Identifier: NCT02603354    
Other Study ID Numbers: 15/001a
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: November 11, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Tooth Discoloration
Tooth Diseases
Stomatognathic Diseases