Clinical trial NCT03192852: Evaluation of Dental Bleaching In-office
Official title: Evaluation of Bleaching In-office With Violet LEd Light (405 nm): Randomized, Controlled Double Blind and Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esthetics, Dental
Keywords: Tooth bleaching color
dental esthetic
Clinical Trial
Violet LED light
Violet LED
color
sensibility
dental aesthetic
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2017-06-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Color Evaluation
timeFrame: baseline
measure: Color Evaluation
timeFrame: 3 months
Secondary outcomes:
measure: Pain measured with Visual Analogue Scale (VAS)
timeFrame: baseline
measure: Pain measured with Visual Analogue Scale (VAS)
timeFrame: 3 months
measure: Quality of life measured with Psychosocial Impact Questionnaire
timeFrame: baseline
measure: Quality of life measured with Psychosocial Impact Questionnaire
timeFrame: 3 months
measure: Histomorphometric evaluation
timeFrame: baseline
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Nove de Julho (UNINOVE)
Study officials:
affiliation: University of Nove de Julho
name: Ana EC Santos, MS
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.