Evaluation of Dental Bleaching In-office (Bleaching)

Evaluation of Bleaching In-office With Violet LEd Light (405 nm): Randomized, Controlled Double Blind and Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Esthetics, Dental
• Intervention / Treatment: Other: dental bleaching; Procedure: Gingivoplasty

Detailed Description

This randomized, blind controlled trial has the objective of evaluate colorimetric changes after supervised whitening treatment, in-office, using Violet LED light of 405 nm associated or not to the use of carbamide peroxide 35% gel. Eighty patients, of which 20 with aesthetics desires to be submitted to gingivoplasty surgery, will be divided into four groups. Group 1 will receive whitening only with Violet LED light (405 nm). Group 2 will receive a whitening treatment combination of Violet LED light with carbamide peroxide 35% gel. Patients of Group 3 will receive a whitening treatment with hydrogen peroxide 35% and Group 4 will be submitted to the gingivoplasty surgery procedure, for aesthetic desire, after whitening treatment with Violet LED light (405 nm) 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 (SpectroShade™ Micro MHT Optic Research). The sensibility degree will be measured by the Visual Analogue Scale (VAS) in each session and in all groups. The gum tissues removed during the gingivoplasty in Group 4, will be histomorphometric analyzed to measure possible inflammatory gum changes by the Violet LED light (405 nm) irradiation. The degree of satisfaction of the patient and the life quality after aesthetic result achieved will be evaluated. The results will be presented by means and standard deviation. After checking the normality of the data, a one-way ANOVA will be performed. In case the data do not follow a normal distribution, it will be utilized the Kruskal-Wallis test and a value of p <0.05.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01504-001
    • University of Nove de Julho (UNINOVE)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Violet LED (405 nm)+ gel placebo; 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; dental bleaching can be achieved with light, light+ peroxide carbamide gel, or only with peroxide carbamide gel
Experimental: HP 35% + Violet LED + Gingivoplasty; 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; dental bleaching can be achieved with light, light+ peroxide carbamide gel, or only with peroxide carbamide gel; Procedure: Gingivoplasty; gengivoplasty will be realized to in illuminated tissue an no illuminated tissue to morphometrically evaluate the tissue
Active Comparator: Violet LED + CP 35%; 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; dental bleaching can be achieved with light, light+ peroxide carbamide gel, or only with peroxide carbamide gel
Active Comparator: HP 35%; 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; dental bleaching can be achieved with light, light+ peroxide carbamide gel, or only with peroxide carbamide gel
Active Comparator: CP 35%; 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; dental bleaching can be achieved with light, light+ peroxide carbamide gel, or only with peroxide carbamide gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histomorphometric evaluation	will be histomorphometric analyzed to measure possible inflammatory gum changes by the Violet LED light (405 nm) irradiation.	baseline
Pain measured with Visual Analogue Scale (VAS)	The pain will be evaluated through the Visual Analogue Scale (VAS) at each session before and after bleaching in the 4 groups.	baseline
Pain measured with Visual Analogue Scale (VAS)	The pain will be assessed through the Visual Analogue Scale (VAS) 3 months after the end of tooth whitening in the 4 groups.	3 months
Quality of life measured with Psychosocial Impact Questionnaire	Quality of life will be assessed through the Psychosocial Impact of Dental Aesthetics Questionnaire validated for Brazil at the Federal University of São Paulo (UNIFESP)	baseline
Quality of life measured with Psychosocial Impact Questionnaire	Quality of life will be evaluated through the Psychosocial Impact Questionnaire of the Dental Internship validated for Brazil at the Federal University of São Paulo (UNIFESP) 3 months after the end of the bleaching.	3 months

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Investigators: Study Chair: Ana EC Santos, MS, University of Nove de Julho

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: June 16, 2017
• First Posted (Actual): June 20, 2017

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Clinical Trial; color; Tooth bleaching color; dental esthetic; Violet LED light; Violet LED; sensibility; dental aesthetic
• Other Study ID Numbers: 2.034.518

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After completing the data search, it is published in indexed journals with high impact factor

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No