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OpenTrials
Completed

NCT Number: NCT03192852

Evaluation of Dental Bleaching In-office

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nove de Julho (UNINOVE)

São Paulo, 01504-001, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Dental bleaching

Other

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

Gingivoplasty

Procedure

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

Primary outcomes

  1. Color Evaluation

    Time frame: baseline

    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

  2. Color Evaluation

    Time frame: 3 months

    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

Secondary outcomes

  1. Pain measured with Visual Analogue Scale (VAS)

    Time frame: baseline

    The pain will be evaluated through the Visual Analogue Scale (VAS) at each session before and after bleaching in the 4 groups.

  2. Pain measured with Visual Analogue Scale (VAS)

    Time frame: 3 months

    The pain will be assessed through the Visual Analogue Scale (VAS) 3 months after the end of tooth whitening in the 4 groups.

  3. Quality of life measured with Psychosocial Impact Questionnaire

    Time frame: baseline

    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)

  4. Quality of life measured with Psychosocial Impact Questionnaire

    Time frame: 3 months

    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.

  5. Histomorphometric evaluation

    Time frame: baseline

    will be histomorphometric analyzed to measure possible inflammatory gum changes by the Violet LED light (405 nm) irradiation.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

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

Acronym: Bleaching

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 20, 2017
Registry last updated
Jun 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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