Longevity and Effectiveness of Bleaching in Healthy and Smokers Patients

NCT02017873 | Completed Phase 4 DMC

• 1 other identifier: Nº 2013/41 FOUCH
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 2

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.

Conditions

Dentin Sensitivity

Keywords

bleaching; smokers; effectiveness; pain

Outcome Measures

Primary Outcomes (1)

• Color

  Objective ( Vita Easy shade ), Subjective measurement

  1, 2, 3, 4, 8 weeks and 3, 6, 9 and 12 month

Secondary Outcomes (1)

• Sensitivity

  1, 2, 3, 4, 8 weeks 3, 6, 9,12 month

Study Arms (2)

healthy patients bleaching

ACTIVE COMPARATOR

Healthy patients Peroxide Carbamide 10% - Dental bleaching treatment

Drug: Peroxide Carbamide 10% - Dental bleaching treatment

Smokers bleaching

EXPERIMENTAL

smokers patients Peroxide Carbamide 10% - Dental bleaching treatment

Drug: Peroxide Carbamide 10% - Dental bleaching treatment

Interventions

Peroxide Carbamide 10% - Dental bleaching treatment DRUG

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

Also known as: FGM Peroxide Carbamide ( Joinville , Brazil )

Smokers bleaching; healthy patients bleaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chile: lead

Study Sites (2)

Juliana Larocca de Geus

Ponta Grossa, Brazil

Location

Faculty of Dentistry - University of Chile

Santiago, Metropólitana, Chile

Location

Related Publications (2)

• de Geus JL, Bersezio C, Urrutia J, Yamada T, Fernandez E, Loguercio AD, Reis A, Kossatz S. Effectiveness of and tooth sensitivity with at-home bleaching in smokers: a multicenter clinical trial. J Am Dent Assoc. 2015 Apr;146(4):233-40. doi: 10.1016/j.adaj.2014.12.014.

  PMID: 25819654 BACKGROUND

• de Geus JL, de Lara MB, Hanzen TA, Fernandez E, Loguercio AD, Kossatz S, Reis A. One-year follow-up of at-home bleaching in smokers before and after dental prophylaxis. J Dent. 2015 Nov;43(11):1346-51. doi: 10.1016/j.jdent.2015.08.009. Epub 2015 Aug 21.

  PMID: 26303401 DERIVED

MeSH Terms

Conditions

Dentin Sensitivity; Pain

Interventions

Carbamide Peroxide

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peroxides; Oxides; Anions; Ions; Electrolytes; Inorganic Chemicals; Reactive Oxygen Species; Free Radicals; Oxygen Compounds; Urea; Amides; Organic Chemicals

Study Officials

• Eduardo Fernandez, Prof.

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Eduardo Maximiliano Fernández Godoy

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 23, 2013
• Study Start: December 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

BR (1); CL (1)