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Longevity and Effectiveness of Bleaching in Healthy and Smokers Patients

NCT02017873 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-05-27

No results posted yet for this study

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.

Conditions

  • Dentin Sensitivity

Interventions

DRUG

Peroxide Carbamide 10% - Dental bleaching treatment

During 3 hours in 3 weeks of bleaching in both groups in healthy patients and smokers patients

Sponsors & Collaborators

  • University of Chile

    lead OTHER

Principal Investigators

  • Eduardo Fernandez, Prof. · University of Chile

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Brazil
  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02017873 on ClinicalTrials.gov