"Evaluation of the Effectiveness and Longevity Post Whitening Carbamide Peroxide 10% in Smokers and Nonsmokers. Double-blind Multicenter Clinical Trial. "
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Color
研究概览
简要总结
The main objective of this study is to evaluate the effectiveness and longevity of color and Tooth sensitivity of patients undergoing home whitening peroxide 10% carbamide ( Whiteness Perfect , FGM , Joinville , Santa Catarina , Brazil) , and the relationship with the cigarette use for tooth whitening. They will be selected 120 patients with incisors darker than A2, higher plants will be divided into 2 groups per center (n = 30 ) , GE - Group Experimental ( smoking) and GC - Group Control ( non-smoking) . For the two groups will be used Carbamide peroxide 10% for 3 hours daily for a period of 3 weeks. Color will evaluated through the Vita Classical scale and Vita Easyshade Spectrophotometer in the periods: Home , for tooth whitening (1st , 2nd and 3rd week) and post- whitening ( 1 week and 1 month , 2 and 3 months). Patients recorded the perceived sensitivity through Numerical Analogue Scale (NRS ) with values from 0 to 4, where 0 = no sensation, 1 = mild, 2 = moderate, 3 = severe and 4 = significant , also in the Visual Analogue Scale (VAS ), with values from 0 to 10 where 0 = 10 = severe tenderness and sensitivity. for color analysis will be made two-way ANOVA (group vs. treatment time ), being Over time the repeated measure ( α = 0.05). Test will be held on Tukey to contrast the average ( α = 0.05). The sensitivity will be evaluated by the Fisher exact test . It is expected that there is no difference on the effectiveness of home whitening and tooth sensitivity between smokers and nonsmokers.
详细描述
This study will be conducted under the CONSORT recommendations and respecting the principles of Helsinsky convention and corresponds to a multicenter study in conjunction with the University of Ponta Grossa Brazil (Deputy resolution protocol and ethics committee (Appendix A and B ) . Will be invited to participate in the study to patients who come to the clinic through FOUCH public posters. Subsequently 120 volunteers will be selected on the criteria that qualify inclusion and exclusion from the study will be reported all volunteers were examined not qualify under the criteria for inclusion as part of the initial n , according to CONSORT recommendations .
After signing the informed ( TCLE ) consent (Appendix 3 ) shall be made prophylaxis teeth of the upper and lower teeth , for the removal of extrinsic stains jet sodium bicarbonate ( Profi class , Ribeirao Preto , Sao Paulo , Brazil) , two weeks before the beginning of tooth whitening.
Inclusion and exclusion criteria:
Patients included in this study must be over 18, in good general health and buccal, have teeth free of carious lesions and periodontal disease, which agree with the informed consent document . And the color of the anterior teeth higher is classified as A2 or greater value , according to the scale VITA Classical (Vita Zahnfabrik, Bad Sackingen, Germany) and the spectrophotometer Easyshade Vita (Vita Zahnfabrik, Bad Sackingen, Germany). Evaluation of color through the VITA scale Classical will be made independently by two calibrated investigators and blind.
Be excluded from the study patients: they have already made treatment tooth whitening, or dental prosthesis having options at the upper front teeth , who are pregnant or lactating , presenting gingival recession, sensitivity dental, endodontic treatment in anterior maxillary teeth, which have a coloring severe internal, if they have non-carious cervical lesions, are taking medications , using fixed orthodontic appliances, submit bruxism habits, which have visible teeth cranks and those who are not available to attend the controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients included in this study must be over 18 years with good general and oral health
- •Free teeth having carious lesions and periodontal disease agree with the informed consent document
- •The color of the upper anterior teeth is classified as A2 or greater value, according to the scale VITA Classical (Vita Zahnfabrik, Bad Sackingen, Germany) and the spectrophotometer Easyshade Vita (Vita Zahnfabrik, Bad Sackingen, Germany).
排除标准
- •Have already made treatment tooth whitening
- •Dental prosthesis having options at the upper front teeth
- •Who are pregnant or lactating
- •Presenting gingival recession
- •Tooth sensitivity
- •Endodontic treatment in anterior maxillary teeth
- •Which have a severe internal coloring
- •Cervical lesions carious
- •Taking medications (AINES)
- •Fixed orthodontic appliances
- •Submit bruxism habits
- •Having visible cracks in teeth
- •Those who are not available to attend the controls.
研究组 & 干预措施
healthy patients bleaching
Healthy patients Peroxide Carbamide 10% - Dental bleaching treatment
干预措施: Peroxide Carbamide 10% - Dental bleaching treatment (Drug)
Smokers bleaching
smokers patients Peroxide Carbamide 10% - Dental bleaching treatment
干预措施: Peroxide Carbamide 10% - Dental bleaching treatment (Drug)
结局指标
主要结局
Color
时间窗: 1, 2, 3, 4, 8 weeks and 3, 6, 9 and 12 month
Objective ( Vita Easy shade ), Subjective measurement
次要结局
- Sensitivity(1, 2, 3, 4, 8 weeks 3, 6, 9,12 month)
研究者
Eduardo Fernandez
Eduardo Maximiliano Fernández Godoy
University of Chile
