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

NCT02067715 | Completed

• 1 other identifier: UFS001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Discoloration

Keywords

Tooth Discoloration; Bleaching Agents; Tooth Bleaching

Outcome Measures

Primary Outcomes (1)

• Tooth sensitivity

  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.

  During the bleaching procedure

Secondary Outcomes (1)

• Bleaching Effectiveness

  Before the bleaching procedures and 7 days after this.

Study Arms (2)

Sealed bleaching Protocol

EXPERIMENTAL

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

Conventional Bleaching Protocol

ACTIVE COMPARATOR

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

Interventions

Tooth bleaching DRUG

The bleaching agent will be used in a single-application of 45 minutes.

Also known as: 35% hydrogen peroxide based bleaching agent, Whiteness HP Maxx, FGM, Joinville, SC, Brazil.

Conventional Bleaching Protocol; Sealed bleaching Protocol

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Universidade Federal de Sergipe: lead

Study Sites (1)

Universidade Federal de Sergipe

Aracaju, Sergipe, 49060100, Brazil

Location

Related Publications (2)

• Reis A, Tay LY, Herrera DR, Kossatz S, Loguercio AD. Clinical effects of prolonged application time of an in-office bleaching gel. Oper Dent. 2011 Nov-Dec;36(6):590-6. doi: 10.2341/10-173-C. Epub 2011 Sep 13.

  PMID: 21913864 BACKGROUND

• Kwon SR, Wertz PW, Dawson DV, Cobb DS, Denehy G. The relationship of hydrogen peroxide exposure protocol to bleaching efficacy. Oper Dent. 2013 Mar-Apr;38(2):177-85. doi: 10.2341/11-351-L. Epub 2012 Jul 7.

  PMID: 22770431 BACKGROUND

MeSH Terms

Conditions

Tooth Discoloration

Interventions

Tooth Bleaching

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Esthetics, Dental; Dentistry

Study Officials

• Andre L Faria-e-Silva, PhD

  Universidade Federal de Sergipe

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 15, 2014
• First Posted: February 20, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 1, 2015

Record last verified: 2015-05

Locations

BR (1)