Evaluation of Bleaching In-office With Violet LEd Light (405 nm): Randomized, Controlled Double Blind and Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Color Evaluation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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;
- •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).
研究组 & 干预措施
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
干预措施: dental bleaching (Other)
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
干预措施: dental bleaching (Other)
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
干预措施: dental bleaching (Other)
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.
干预措施: dental bleaching (Other)
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.
干预措施: Gingivoplasty (Procedure)
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)
干预措施: dental bleaching (Other)
结局指标
主要结局
Color Evaluation
时间窗: 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
Color Evaluation
时间窗: 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
次要结局
- Histomorphometric evaluation(baseline)
- Pain measured with Visual Analogue Scale (VAS)(3 months)
- Quality of life measured with Psychosocial Impact Questionnaire(3 months)
- Pain measured with Visual Analogue Scale (VAS)(baseline)
- Quality of life measured with Psychosocial Impact Questionnaire(baseline)
研究者
Anna Carolina Ratto Tempestini Horliana
Professor of postgraduate program in Biophotonics Applied to Health Sciences, University of Nove de Julho, UNINOVE, São Paulo, Brazil
University of Nove de Julho