Influence of Tooth Whitening on Changes in Quality of Life: a Randomized Double-blinded Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- change from psychosocial impact of dental aesthetics at one year
研究概览
简要总结
Lighter tooth color may improve patient satisfaction with facial aesthetics. Few data exist regarding the impact and association of of tooth color connection with quality of life.The purpose of this research is to explore the extent to which patients perceive a color change and difference in quality of life induced by tooth whitening after one week and after one year.
A plan is to assess 100 participants for eligibility (aged 18-30 years) and to enroll at least 70 and randomly assign to an active or a control group (equal number of participans in each group). Their anterior teeth in both jaws will be bleached with a photo-activated whitening gel, or will be subjected to a placebo. Lightness, chroma and translucency of teeth will be assessed before (T0), one week (T1) and one year (T2) after the procedure by a spectrophotometer. The subjects in both occasions will administrate the psychometric instrumetns Psychosocial Impact of Dental Aesthetics Questionnaire, Orofacial Esthetic Scale, Oral Health Impact Profile and Smile Esthetics Related Quality of Life. Influence of personality traits on the perception of changes in smile aesthetics and qualiy of life will be also explored (extraversion, conscientiousness, neuroticism, agreeableness, openness to experience, perfectionism, self-esteem, body image).
详细描述
The aim of the trial is to explore influence of teeth whitening on the perception of dentofacial aesthetics. Influence of personality traits on this relationship is also to be explored (extraversion, conscientiousness, neuroticism, agreeableness, openness to experience, perfectionism, self-esteem, body image). All total of 70 examinees (young adults) at baseline (T0) will administrate psychometric instruments Oral Health Impact Profile (OHIP), Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ), Orofacial Esthetic Scale (OES), Smile esthetics related quality of life (SERQoL), Big Five Inventory (BFI), Rosenberg's Self-Esteem Scale (RSS), Frost Multidimensional Perfectionism Sale (FMPS), and a newly developed short form instruments for body image, perfectionism, self-esteem and perception of body appearance. The elements of tooth color (lightness, chroma and translucency) will be assessed by spectrophotometer (SpectroShade, MHT, Italy) at baseline (T0), after one week (T1) and after one year (T2). The precision and accuracy of the instrument will be checked by repeated measurements and by comparison with the gold standard. Examinees will be randomly assigned to the active or control group using the "random between" function in Microsoft Excell. Teeth of half of subjects will be bleached using a lamp and photo-activated bleaching gel (Signal Easy Lamp Plus and Signal Fast Professional plus set, Signal, Unilever, Argentina), while the remaining half will be subjected to a placebo, i.e. a gel without active substance.
After one week (T1) the elements of tooth color will be assessed again and color change will be calculated (ΔE). Pain induced by whitening procedure will be assessed by using 10mm visual analogue scale. Participants will administrate instruments OHIP, PIDAQ, OES, SERQoL and short form instruments for body image, perfectionism, self-esteem and perception of body appearance. A year after the whitening procedure (T2) the elements of toth color will be assessed again and the same instruments as in T1 will be administrated. The short-term (T0-T1) and long-term (T0-T2) effect of teeth whitening on the changes in perception of dentofacial aesthetics and quality of life is to be analyzed.
The results will be analysed by using t-test, analysis of variance and covariance, and Pearson correlations.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •presence of a complete anterior tooth segment free of caries
- •anterior tooth segment free of fillings
- •anterior tooth segment free of prosthetic restorations
排除标准
- •Gingivitis present
- •Malocclusion present (Index of Orthodontic Treatment Need-Dental Health Component ≤3 and Aesthetic Component ≤4)
研究组 & 干预措施
whitening photoactivation gel
exposure to hydrogen gel and photoactivation for teeth whitening
干预措施: whitening photoactivation gel (Procedure)
placebo
exposure to gel without active whitening substance and the same photoactivation source as active comparator
干预措施: placebo (Procedure)
结局指标
主要结局
change from psychosocial impact of dental aesthetics at one year
时间窗: one year after whitening
psychosocial impact of dental aesthetics measured by Psychosocial impacr of dental aesthetics questionnaire (PIDAQ; scalar points, range 0-32)
change from baseline oral health-related quality of life at one year
时间窗: one year after whitening
oral health-related quality of life measured by Oral health impact profile instrument (OHIP; scalar points, range 0-56)
change from baseline color at one year
时间窗: one year after whitening
change of color of teeth (ΔE) by spectrophotometer in scalar points (range 1-10)
change from baseline smile esthetics related quality of life at one week
时间窗: one week after whitening
smile esthetics related quality of life measured by Smile esthetics related quality of life quaetionnaire (SERQoL; scalar points, range 4-20)
change from baseline satisfaction with orofacial aesthetics at one year
时间窗: one year after whitening
satisfaction with orofacial aesthetics measured by Orofacial esthetic scale (OES; scalar points, range 1-45)
change from psychosocial impact of dental aesthetics at one week
时间窗: one week after whitening
psychosocial impact of dental aesthetics measured by Psychosocial impacr of dental aesthetics questionnaire (PIDAQ; scalar points, range 0-32)
change from baseline smile esthetics related quality of life at one year
时间窗: one year after whitening
smile esthetics related quality of life measured by Smile esthetics related quality of life quaetionnaire (SERQoL; scalar points, range 4-20)
change from baseline oral health-related quality of life at one week
时间窗: one week after whitening
oral health-related quality of life measured by Oral health impact profile instrument (OHIP; scalar points, range 0-56)
change from baseline color at one week
时间窗: one week after whitening
change of color of teeth (ΔE) by spectrophotometer in scalar points (range 1-10)
change from baseline satisfaction with orofacial aesthetics at one week
时间窗: one week after whitening
satisfaction with orofacial aesthetics measured by Orofacial esthetic scale (OES; scalar points, range 1-45)
次要结局
- discomfort with teeth whitening(one week after whitening)
- change from baseline chroma at one year(one year after whitening)
- change from baseline chroma at one week(one week after whitening)
- change from baseline translucency at one week(one week after whitening)
- change from baseline lightness at one year(one year after whitening)
- change from baseline translucency at one year(one year after whitening)
- change from baseline lightness at one week(one week after whitening)
研究者
Daniela Kovacevic Pavicic
professor
University of Rijeka