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Evaluation of Dental Bleaching In-office

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03192852
Acronym
Bleaching
Enrollment
80
Registered
2017-06-20
Start date
2018-07-01
Completion date
2019-12-20
Last updated
2023-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esthetics, Dental

Keywords

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

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.

Interventions

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

PROCEDUREGingivoplasty

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

Sponsors

University of Nove de Julho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Color EvaluationbaselineColor 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

Secondary

MeasureTime frameDescription
Pain measured with Visual Analogue Scale (VAS)baselineThe pain will be evaluated through the Visual Analogue Scale (VAS) at each session before and after bleaching in the 4 groups.
Quality of life measured with Psychosocial Impact QuestionnairebaselineQuality of life will be assessed through the Psychosocial Impact of Dental Aesthetics Questionnaire validated for Brazil at the Federal University of São Paulo (UNIFESP)
Histomorphometric evaluationbaselinewill be histomorphometric analyzed to measure possible inflammatory gum changes by the Violet LED light (405 nm) irradiation.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026