Trial record 2 of 2 for:    Open Studies | "Tooth Bleaching"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Universidade Federal de Sergipe
Sponsor:
Information provided by (Responsible Party):
André Luis Faria e Silva, Universidade Federal de Sergipe
ClinicalTrials.gov Identifier:
NCT02067715
First received: February 15, 2014
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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 Intervention
Tooth Discoloration
Drug: Tooth bleaching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Sealed In-office Bleaching Technique: Randomized Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Sergipe:

Primary Outcome Measures:
  • Tooth sensitivity [ Time Frame: During the bleaching procedure ] [ Designated as safety issue: Yes ]
    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:
  • Bleaching Effectiveness [ Time Frame: Before the bleaching procedures and 7 days after this. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 34
Study Start Date: February 2014
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02067715

Contacts
Contact: Andre L Faria-e-Silva, PhD 55 79 21051824 fariaesilva.andre@gmail.com

Locations
Brazil
Universidade Federal de Sergipe Recruiting
Aracaju, SE, Brazil, 49060100
Contact: Andre L Faria-e-Silva, PhD    55 79 21051824    fariaesilva.andre@gmail.ocom   
Principal Investigator: Andre L Faria-e-Silva, PhD         
Sponsors and Collaborators
Universidade Federal de Sergipe
Investigators
Study Chair: Andre L Faria-e-Silva, PhD Universidade Federal de Sergipe
  More Information

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
Study First Received: February 15, 2014
Last Updated: February 18, 2014
Health Authority: United States: Food and Drug Administration
Brazil: National Health Surveillance Agency

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014