Evaluation of Dental Bleaching In-office

NCT03192852 | Completed DMC

• 1 other identifier: 2.034.518
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

We aim to evaluate colorimetric changes after supervised whitening treatment, using Violet LED light associated or not with carbamide peroxide 35% gel. 80 will be divided into: Group 1 - Violet LED light, Group 2 Violet LED light + carbamide peroxide 35% gel, Group 3 -hydrogen peroxide 35% and Group 4 will be submitted to the gingivoplasty surgery procedure, for aesthetic desire, after whitening treatment with Violet LED light without gel. The colorimetric changes will be measured before, right after each whitening session in the end of the period of 3 months, through the Vitapan Classical (Vita) color scale, and by digital spectrophotometer. The sensibility degree will be measured by the Visual Analogue Scale (VAS) . The gum tissues Group 4, will be analyzed by histomorphometrically. Quality of life will be evaluated.

Conditions

Esthetics, Dental

Keywords

Tooth bleaching color; dental esthetic; Clinical Trial; Violet LED light; Violet LED; color; sensibility; dental aesthetic

Outcome Measures

Primary Outcomes (2)

• Color Evaluation

  Color evaluation will be done before and after each bleaching session through the Vita Classical scale (VITA Zanhnfabrik, BadSӓckingrn, Germany) and SpectroShade ™ Micro MHT Optic Research by a previously trained and blind evaluator in the 4 groups

  baseline

• Color Evaluation

  Color evaluation will be done 3 months after bleaching through the Vita Classical scale (VITA Zanhnfabrik, BadSӓckingrn, Germany) and SpectroShade ™ Micro MHT Optic Research by a previously trained and blind evaluator in the 4 groups

  3 months

Secondary Outcomes (5)

• Pain measured with Visual Analogue Scale (VAS)

  baseline

• Pain measured with Visual Analogue Scale (VAS)

  3 months

• Quality of life measured with Psychosocial Impact Questionnaire

  baseline

• Quality of life measured with Psychosocial Impact Questionnaire

  3 months

• Histomorphometric evaluation

  baseline

Study Arms (5)

Violet LED (405 nm)+ gel placebo

EXPERIMENTAL

20 patients will be submitted to dental bleaching involving the teeth 15-25 and 45 - 35 with Violet LED 405 nm (Bright Max Whitening, MMO, São Carlos, SP, Brazil) with gingival barrier + gel placebo

Other: dental bleaching

Violet LED + CP 35%

ACTIVE COMPARATOR

20 patients will be submitted to dental bleaching involving the teeth 15-25 and 45 - 35 with carbamide peroxide 35% ( Whiteform - Fórmula \& Ação, São Paulo, Brazil) actived with Violet LED 405 nm (Bright Max Whitening, MMO, São Carlos, SP, Brazil) with gingival barrier

Other: dental bleaching

HP 35%

ACTIVE COMPARATOR

20 patients will be submitted to dental bleaching involving the teeth 15-25 and 45 - 35 with hydrogen peroxide 35% (Whiteness HP, FGM, Joinvile, SC, Brasil) and gingival barrier

Other: dental bleaching

HP 35% + Violet LED + Gingivoplasty

EXPERIMENTAL

20 patients will be submitted to dental bleaching involving the teeth 15-25 and 45 - 35 with Violet LED 405 nm (Bright Max Whitening, MMO, São Carlos, SP, Brazil) with gingival barrier split-mouth at first session. After 48 hours will be do Gingivoplasty.

Other: dental bleaching; Procedure: Gingivoplasty

CP 35%

ACTIVE COMPARATOR

20 patients will be submitted to dental bleaching involving the teeth 15-25 and 45 - 35 with carbamide peroxide 35% ( Whiteform - Fórmula \& Ação, São Paulo, Brazil)

Other: dental bleaching

Interventions

dental bleaching OTHER

dental bleaching can be achieved with light, light+ peroxide carbamide gel, or only with peroxide carbamide gel

CP 35%; HP 35%; HP 35% + Violet LED + Gingivoplasty; Violet LED (405 nm)+ gel placebo; Violet LED + CP 35%

Gingivoplasty PROCEDURE

gengivoplasty will be realized to in illuminated tissue an no illuminated tissue to morphometrically evaluate the tissue

HP 35% + Violet LED + Gingivoplasty

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• negative medical history,
• Good systemic and oral health
• Patients with aesthetic complaint of discoloration of upper and lower teeth
• Patients with aesthetic desire for gingivoplasty, regardless of color in the baseline (Group 4), without the need for a prosthetic procedure and with sufficient gingiva inserted
• Color in the baseline higher than the A2 of the vita scale for groups 1, 2 and 3.

You may not qualify if:

• Patients with dentin hypersensitivity, incisal and occlusal wear or open cavities;
• Patients with pulp alterations;
• Carriers of dental anomalies;
• Patients with dental fractures who do not have restorations on the buccal surface of the teeth to be cleared;
• Patients who have had dental bleaching for less than 2 years;
• Holders of fixed appliances, orthopedic;
• Teeth pigmented by intrinsic factors;
• Smokers;
• Pregnant and Infants;
• Patients reporting adverse reactions to Hydrogen Peroxide;
• Patients who are taking ferrous sulfate medication;
• Patients who use chronic decorticosteroids, as well as volunteers who are taking analgesics or anti-inflammatories.
• Individual or removable prosthesis holders on the analyzed teeth will also be excluded or patients with endodontically treated teeth (Teeth 15-25 and 45-35).

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

University of Nove de Julho (UNINOVE)

São Paulo, 01504-001, Brazil

Location

Related Publications (2)

• Santos AECG, Bussadori SK, Pinto MM, Brugnera AJ, Zanin FAA, Silva T, Martinbianco ALC, Pantano Junior DA, Rodrigues MFSD, Artese HPC, Deana AM, Motta LJ, Horliana ACRT. Clinical evaluation of in-office tooth whitening with violet LED (405 nm): A double-blind randomized controlled clinical trial. Photodiagnosis Photodyn Ther. 2021 Sep;35:102385. doi: 10.1016/j.pdpdt.2021.102385. Epub 2021 Jun 9.

  PMID: 34116249 DERIVED

• Santos AECGD, Bussadori SK, Pinto MM, Pantano Junior DA, Brugnera A Jr, Zanin FAA, Rodrigues MFSD, Motta LJ, Horliana ACRT. Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial. BMJ Open. 2018 Sep 4;8(9):e021414. doi: 10.1136/bmjopen-2017-021414.

  PMID: 30181185 DERIVED

MeSH Terms

Interventions

tooth-bleaching agent, Opalescence; Gingivoplasty

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry; Periodontics

Study Officials

• Ana EC Santos, MS

  University of Nove de Julho

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: We will use a gel with no effect only in the fourth session of group 3 to match the number of sessions in relation to the other groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of postgraduate program in Biophotonics Applied to Health Sciences, University of Nove de Julho, UNINOVE, São Paulo, Brazil

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 20, 2017
• Study Start: July 1, 2018
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: June 29, 2023

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)