Clinical trial NCT03380702: Influence of Tooth Whitening on Changes in Quality of Life
Official title: Influence of Tooth Whitening on Changes in Quality of Life: a Randomized Double-blinded Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Discoloration
Quality of Life
Keywords: colour
dental aesthetics
perceptions
quality of life
tooth whitening
Lead sponsor: University of Rijeka
Sponsor class: OTHER
Collaborators: name: University of Rijeka
First posted: 2017-12-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RANDOMIZED DOUBLE-BLINDED PLACEBO-CONTROLLED TRIAL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: change from baseline color at one week
timeFrame: one week after whitening
measure: change from baseline color at one year
timeFrame: one year after whitening
measure: change from psychosocial impact of dental aesthetics at one week
timeFrame: one week after whitening
measure: change from psychosocial impact of dental aesthetics at one year
timeFrame: one year after whitening
measure: change from baseline smile esthetics related quality of life at one week
timeFrame: one week after whitening
measure: change from baseline smile esthetics related quality of life at one year
timeFrame: one year after whitening
measure: change from baseline satisfaction with orofacial aesthetics at one week
timeFrame: one week after whitening
measure: change from baseline satisfaction with orofacial aesthetics at one year
timeFrame: one year after whitening
measure: change from baseline oral health-related quality of life at one week
timeFrame: one week after whitening
measure: change from baseline oral health-related quality of life at one year
timeFrame: one year after whitening
Secondary outcomes:
measure: change from baseline lightness at one week
timeFrame: one week after whitening
measure: change from baseline lightness at one year
timeFrame: one year after whitening
measure: change from baseline chroma at one week
timeFrame: one week after whitening
measure: change from baseline chroma at one year
timeFrame: one year after whitening
measure: change from baseline translucency at one week
timeFrame: one week after whitening
measure: change from baseline translucency at one year
timeFrame: one year after whitening
measure: discomfort with teeth whitening
timeFrame: one week after whitening
Other outcomes:
Locations:
city: Rijeka
country: Croatia
facility: Medical faculty University of Rijeka
Study officials:
References:
citation: Kovacevic Pavicic D, Pavlic A, Kinkela Devcic M, Lajnert V, Spalj S. Tooth Color as a Predictor of Oral Health-Related Quality of Life in Young Adults. J Prosthodont. 2019 Apr;28(4):e886-e892. doi: 10.1111/jopr.12666. Epub 2017 Oct 31.
citation: Kovacevic Pavicic D, Kolceg M, Lajnert V, Pavlic A, Spalj S. Changes in quality of life induced by tooth whitening are not influenced by global self-esteem: a randomized double-blind placebo-controlled trial. Odontology. 2020 Jan;108(1):143-151. doi: 10.1007/s10266-019-00442-6. Epub 2019 Jul 9.