Influence of Tooth Whitening on Changes in Quality of Life

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Influence of Tooth Whitening on Changes in Quality of Life: a Randomized Double-blinded Placebo-controlled Trial

Conditions
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Tooth Discoloration, Quality of Life

Intervention / Treatment
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* Procedure: whitening photoactivation gel
* Procedure: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presence of a complete anterior tooth segment free of caries anterior tooth segment free of fillings anterior tooth segment free of prosthetic restorations Exclusion Criteria: Gingivitis present Malocclusion present (Index of Orthodontic Treatment Need-Dental Health Component ≤3 and Aesthetic Component ≤4)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RANDOMIZED DOUBLE-BLINDED PLACEBO-CONTROLLED TRIAL
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: whitening photoactivation gel<br>exposure to hydrogen gel and photoactivation for teeth whitening | Procedure: whitening photoactivation gel<br>* 35 subjects in active comparator group<br>|
| Placebo Comparator: placebo<br>exposure to gel without active whitening substance and the same photoactivation source as active comparator | Procedure: placebo<br>* 35 subjects in placebo comparator group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline color at one week | change of color of teeth (ΔE) by spectrophotometer in scalar points (range 1-10) | one week after whitening | 
| change from baseline color at one year | change of color of teeth (ΔE) by spectrophotometer in scalar points (range 1-10) | one year after whitening | 
| change from psychosocial impact of dental aesthetics at one week | psychosocial impact of dental aesthetics measured by Psychosocial impacr of dental aesthetics questionnaire (PIDAQ; scalar points, range 0-32) | one week after whitening | 
| change from psychosocial impact of dental aesthetics at one year | psychosocial impact of dental aesthetics measured by Psychosocial impacr of dental aesthetics questionnaire (PIDAQ; scalar points, range 0-32) | one year after whitening | 
| change from baseline smile esthetics related quality of life at one week | smile esthetics related quality of life measured by Smile esthetics related quality of life quaetionnaire (SERQoL; scalar points, range 4-20) | one week after whitening | 
| change from baseline smile esthetics related quality of life at one year | smile esthetics related quality of life measured by Smile esthetics related quality of life quaetionnaire (SERQoL; scalar points, range 4-20) | one year after whitening | 
| change from baseline satisfaction with orofacial aesthetics at one week | satisfaction with orofacial aesthetics measured by Orofacial esthetic scale (OES; scalar points, range 1-45) | one week after whitening | 
| change from baseline satisfaction with orofacial aesthetics at one year | satisfaction with orofacial aesthetics measured by Orofacial esthetic scale (OES; scalar points, range 1-45) | one year after whitening | 
| change from baseline oral health-related quality of life at one week | oral health-related quality of life measured by Oral health impact profile instrument (OHIP; scalar points, range 0-56) | one week after whitening | 
| change from baseline oral health-related quality of life at one year | oral health-related quality of life measured by Oral health impact profile instrument (OHIP; scalar points, range 0-56) | one year after whitening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline lightness at one week | lightness of teeth measured by spectrophotometer (scalar range 67-83) | one week after whitening | 
| change from baseline lightness at one year | lightness of teeth measured by spectrophotometer (scalar range 67-83) | one year after whitening | 
| change from baseline chroma at one week | chroma of teeth measured by spectrophotometer (range 11-25) | one week after whitening | 
| change from baseline chroma at one year | chroma of teeth measured by spectrophotometer (range 11-25) | one year after whitening | 
| change from baseline translucency at one week | transluceny of teeth measured by spectrophotometer (range 0-13) | one week after whitening | 
| change from baseline translucency at one year | transluceny of teeth measured by spectrophotometer (range 0-13) | one year after whitening | 
| discomfort with teeth whitening | discomfort with teeth whitening assessed by visual-analogue scale (scalar ponts 1-10) | one week after whitening | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colour, dental aesthetics, perceptions, quality of life, tooth whitening