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Longevity and Effectiveness of Bleaching in Healthy and Smokers Patients (BLESMOK)

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ClinicalTrials.gov Identifier: NCT02017873
Recruitment Status : Completed
First Posted : December 23, 2013
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Eduardo Fernandez, University of Chile

Brief Summary:
The main objective of this study is to evaluate the effectiveness and longevity of color and Tooth sensitivity of patients undergoing home whitening peroxide 10% carbamide ( Whiteness Perfect , FGM , Joinville , Santa Catarina , Brazil) , and the relationship with the cigarette use for tooth whitening. They will be selected 120 patients with incisors darker than A2, higher plants will be divided into 2 groups per center (n = 30 ) , GE - Group Experimental ( smoking) and GC - Group Control ( non-smoking) . For the two groups will be used Carbamide peroxide 10% for 3 hours daily for a period of 3 weeks. Color will evaluated through the Vita Classical scale and Vita Easyshade Spectrophotometer in the periods: Home , for tooth whitening (1st , 2nd and 3rd week) and post- whitening ( 1 week and 1 month , 2 and 3 months). Patients recorded the perceived sensitivity through Numerical Analogue Scale (NRS ) with values from 0 to 4, where 0 = no sensation, 1 = mild, 2 = moderate, 3 = severe and 4 = significant , also in the Visual Analogue Scale (VAS ), with values from 0 to 10 where 0 = 10 = severe tenderness and sensitivity. for color analysis will be made two-way ANOVA (group vs. treatment time ), being Over time the repeated measure ( α = 0.05). Test will be held on Tukey to contrast the average ( α = 0.05). The sensitivity will be evaluated by the Fisher exact test . It is expected that there is no difference on the effectiveness of home whitening and tooth sensitivity between smokers and nonsmokers.

Condition or disease Intervention/treatment Phase
Dentin Sensitivity Drug: Peroxide Carbamide 10% - Dental bleaching treatment Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "Evaluation of the Effectiveness and Longevity Post Whitening Carbamide Peroxide 10% in Smokers and Nonsmokers. Double-blind Multicenter Clinical Trial. "
Study Start Date : December 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: healthy patients bleaching
Healthy patients Peroxide Carbamide 10% - Dental bleaching treatment
Drug: Peroxide Carbamide 10% - Dental bleaching treatment
During 3 hours in 3 weeks of bleaching in both groups in healthy patients and smokers patients
Other Name: FGM Peroxide Carbamide ( Joinville , Brazil )

Experimental: Smokers bleaching
smokers patients Peroxide Carbamide 10% - Dental bleaching treatment
Drug: Peroxide Carbamide 10% - Dental bleaching treatment
During 3 hours in 3 weeks of bleaching in both groups in healthy patients and smokers patients
Other Name: FGM Peroxide Carbamide ( Joinville , Brazil )




Primary Outcome Measures :
  1. Color [ Time Frame: 1, 2, 3, 4, 8 weeks and 3, 6, 9 and 12 month ]
    Objective ( Vita Easy shade ), Subjective measurement


Secondary Outcome Measures :
  1. Sensitivity [ Time Frame: 1, 2, 3, 4, 8 weeks 3, 6, 9,12 month ]
    VAS Scale 0-4 Pain Scale



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
Criteria

Inclusion Criteria:

  • Patients included in this study must be over 18 years with good general and oral health
  • Free teeth having carious lesions and periodontal disease agree with the informed consent document
  • The color of the upper anterior teeth is classified as A2 or greater value, according to the scale VITA Classical (Vita Zahnfabrik, Bad Sackingen, Germany) and the spectrophotometer Easyshade Vita (Vita Zahnfabrik, Bad Sackingen, Germany).

Exclusion Criteria:

  • Have already made treatment tooth whitening
  • Dental prosthesis having options at the upper front teeth
  • Who are pregnant or lactating
  • Presenting gingival recession
  • Tooth sensitivity
  • Endodontic treatment in anterior maxillary teeth
  • Which have a severe internal coloring
  • Cervical lesions carious
  • Taking medications (AINES)
  • Fixed orthodontic appliances
  • Submit bruxism habits
  • Having visible cracks in teeth
  • Those who are not available to attend the controls.

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): NCT02017873


Locations
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Brazil
Juliana Larocca de Geus
Ponta Grossa, Brazil
Chile
Faculty of Dentistry - University of Chile
Santiago, Metropólitana, Chile
Sponsors and Collaborators
University of Chile
Investigators
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Principal Investigator: Eduardo Fernandez, Prof. University of Chile

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eduardo Fernandez, Eduardo Maximiliano Fernández Godoy, University of Chile
ClinicalTrials.gov Identifier: NCT02017873     History of Changes
Other Study ID Numbers: Nº 2013/41 FOUCH
First Posted: December 23, 2013    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Keywords provided by Eduardo Fernandez, University of Chile:
bleaching
smokers
effectiveness
pain
Additional relevant MeSH terms:
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Dentin Sensitivity
Tooth Diseases
Stomatognathic Diseases
Carbamide Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents