Quality of Life Clinical Trial
Official title:
Influence of Tooth Whitening on Changes in Quality of Life: a Randomized Double-blinded Placebo-controlled Trial
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).
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.
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