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Effectiveness of Sealed In-office Bleaching Technique: Randomized Controlled Clinical Trial

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ClinicalTrials.gov Identifier: NCT02067715
Recruitment Status : Completed
First Posted : February 20, 2014
Last Update Posted : June 1, 2015
Sponsor:
Information provided by (Responsible Party):
André Luis Faria e Silva, Universidade Federal de Sergipe

Brief Summary:
Thus, the aim of this study is to evaluate the sealed bleaching technique on tooth sensitivity and bleaching efficacy. The hypothesis is that the sealed bleaching technique reduce the tooth sensitivity when compared to conventional technique, without alters the bleaching efficacy.

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Sealed In-office Bleaching Technique: Randomized Controlled Clinical Trial
Study Start Date : February 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sealed bleaching Protocol
The 35% hydrogen peroxide gel will be mixed and applied over the buccal surfaces of teeth. The bleaching agent will remain for 45-min application without replacement of peroxide. However, a customized tray will be placed over the bleaching agent during entire permanence of peroxide (45 minutes).
Drug: Tooth bleaching
The bleaching agent will be used in a single-application of 45 minutes.
Other Name: 35% hydrogen peroxide based bleaching agent, Whiteness HP Maxx, FGM, Joinville, SC, Brazil.
Active Comparator: Conventional Bleaching Protocol
The 35% hydrogen peroxide gel will be mixed and applied over the buccal surfaces of teeth. The bleaching agent will remain for 45-min application without replacement of peroxide.
Drug: Tooth bleaching
The bleaching agent will be used in a single-application of 45 minutes.
Other Name: 35% hydrogen peroxide based bleaching agent, Whiteness HP Maxx, FGM, Joinville, SC, Brazil.



Primary Outcome Measures :
  1. Tooth sensitivity [ Time Frame: During the bleaching procedure ]
    The tooth sensitivity will be assessed using a Visual analogue (VAS) and verbal scales. VAS consisted of a 10-cm color scale from green (no sensitivity) to red (unbearable sensitivity). A slightly air-stream will be applied over the buccal surfaces of the central incisors, and the patients will record their sensitivity perception by pointing with a pen on the scale. The distance between the marking and the border of scale, relative to the absence of sensitivity will be measured. The measurements will be scored according to: 0 - until 2-cm; 1 - between 2.1 and 4-cm; 2 - between 4.1 and 6-cm; 3 - between 6.1 and 8-cm; 4 - between 8.1 and 10-cm. For verbal scale, the patient will relate her/his level of sensitivity in a scale from 0 to 4, while 0 = none, 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe. Participants presenting score different from 0 for any scale in this evaluation time will be excluded.


Secondary Outcome Measures :
  1. Bleaching Effectiveness [ Time Frame: Before the bleaching procedures and 7 days after this. ]
    The color evaluation will be performed using CIE L*a*b* color system, classical Vita guide and Vita bleachguide. For the CIE L*a*b* and classical vita guide, the shade will be determined using a spectrophotometer (Easy Shade Compact, Vita-Zahnfabrik, Bad Säckinge, Germany). The spectrophotometer also will inform the shade in classical Vita guide. The shades of this guide will be arranged in scores from highest (B1) to lowest (C4) values. Two calibrated examiners will evaluate the shade of teeth using the Vita Bleachguide. For calibration purposes, the teeth shades of five participants (whom will be did not include in the sample) will be evaluated individually by each examiner. A level of agreement higher than 80% must be reached before to begin the study evaluation. During the study, if disagreements arose, they will reach a consensus before dismissing the patient. For this guide, the shades also will be arranged in scores from highest (0M1) to lowest (5M3) values.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 years old patients of both genders presenting good general/oral health;
  • All maxillary anterior teeth presenting shade equal or darker than 2M2 at Vita bleachguide guide (Vita-Zahnfabrik, Alemanha)
  • Signed the form accepting to participate of this study.

Exclusion Criteria:

  • Presence of caries lesions, restorations and/or endodontic treatment at any maxillary anterior teeth.
  • Undergone tooth-whitening procedures;
  • Pregnant/lactating;
  • Smokers;
  • Presence of periodontal diseases;
  • Presence of severe tooth discoloration by tetracycline stains or fluorosis;
  • Any kind of medicine, bruxism habits or any other pathology that can cause sensitivity (such as recession, dentin exposure);
  • Continuous use of drugs with anti-inflammatory actions.
  • Presence of tooth hypersensitivity at baseline measurement;
  • Non-attendance to any session of evaluation or bleaching;

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): NCT02067715


Locations
Brazil
Universidade Federal de Sergipe
Aracaju, SE, Brazil, 49060100
Sponsors and Collaborators
Universidade Federal de Sergipe
Investigators
Study Chair: Andre L Faria-e-Silva, PhD Universidade Federal de Sergipe

Publications:
Responsible Party: André Luis Faria e Silva, Dr, Universidade Federal de Sergipe
ClinicalTrials.gov Identifier: NCT02067715     History of Changes
Other Study ID Numbers: UFS001
First Posted: February 20, 2014    Key Record Dates
Last Update Posted: June 1, 2015
Last Verified: May 2015

Keywords provided by André Luis Faria e Silva, Universidade Federal de Sergipe:
Tooth Discoloration
Bleaching Agents
Tooth Bleaching

Additional relevant MeSH terms:
Tooth Discoloration
Tooth Diseases
Stomatognathic Diseases
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents