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Phycosocial Impact of Bleaching Teeth (PSYBLE)

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. Identifier: NCT02605239
Recruitment Status : Completed
First Posted : November 16, 2015
Last Update Posted : November 16, 2015
Information provided by (Responsible Party):
Eduardo Fernandez, University of Chile

Brief Summary:
58 patients between 18 and 76 years who attended the Operative Dentistry Clinic at Dental School, Universidad de Chile, were included in the study. Those patients were bleaching and included in this study and signed a consent form. The patients were treated with 10% carbamide peroxide (CP) gel (Whiteness Perfect, FGM) to each subject with verbal instructions for 3 weeks with daily applications of 1 hour according to manufacturers indications , before and after this procedure was applied again the OHIP-Esthetics , PIDAQ and OES questionnaire form, had 30 minutes to answer it, were completed before , immediately after and one month control post-bleaching procedure.

Condition or disease Intervention/treatment Phase
Tooth Discoloration Drug: Bleaching teeth Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect on Oral Health, Phycosocial Impact and Esthetics Perception of Bleaching Teeth
Study Start Date : March 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Experimental: bleaching teeth
Group of patients will be bleaching with 10% peroxide carbamide , and them will be assessed the impact on dental confidence , impact psychosocial and esthetic perception
Drug: Bleaching teeth
bleaching teeth with carbamide peroxide 10% for 3 weeks
Other Name: bleaching gel

Primary Outcome Measures :
  1. Oral Health and quality of Life [ Time Frame: 1 month ]
    Assesed by OHIP-Esthetics survey

Secondary Outcome Measures :
  1. phycosocial impact [ Time Frame: 1 month ]
    Assesed by PIDAQ survey

  2. esthetics perception [ Time Frame: 1 month ]
    Assesed by OES survey

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT02605239

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Eduardo Fernandez Godoy
Santiago, Chile, 7500505
Sponsors and Collaborators
University of Chile
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Study Director: eduardo fernandez University of Chile

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Eduardo Fernandez, Prof. Dr. Eduardo Fernández, University of Chile Identifier: NCT02605239     History of Changes
Other Study ID Numbers: 2013-18a
First Posted: November 16, 2015    Key Record Dates
Last Update Posted: November 16, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Tooth Discoloration
Tooth Diseases
Stomatognathic Diseases