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Influence of Tooth Whitening on Changes in Quality of Life

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03380702
Enrollment
70
Registered
2017-12-21
Start date
2015-11-01
Completion date
2017-07-30
Last updated
2017-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life, Tooth Discoloration

Keywords

colour, dental aesthetics, perceptions, quality of life, tooth whitening

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.

Interventions

PROCEDUREwhitening photoactivation gel

35 subjects in active comparator group

PROCEDUREplacebo

35 subjects in placebo comparator group

Sponsors

University of Rijeka
CollaboratorOTHER
Daniela Kovacevic Pavicic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

RANDOMIZED DOUBLE-BLINDED PLACEBO-CONTROLLED TRIAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
change from baseline oral health-related quality of life at one yearone year after whiteningoral health-related quality of life measured by Oral health impact profile instrument (OHIP; scalar points, range 0-56)
change from psychosocial impact of dental aesthetics at one weekone week after whiteningpsychosocial impact of dental aesthetics measured by Psychosocial impacr of dental aesthetics questionnaire (PIDAQ; scalar points, range 0-32)
change from psychosocial impact of dental aesthetics at one yearone year after whiteningpsychosocial 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 weekone week after whiteningsmile esthetics related quality of life measured by Smile esthetics related quality of life quaetionnaire (SERQoL; scalar points, range 4-20)
change from baseline smile esthetics related quality of life at one yearone year after whiteningsmile 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 weekone week after whiteningsatisfaction with orofacial aesthetics measured by Orofacial esthetic scale (OES; scalar points, range 1-45)
change from baseline satisfaction with orofacial aesthetics at one yearone year after whiteningsatisfaction with orofacial aesthetics measured by Orofacial esthetic scale (OES; scalar points, range 1-45)
change from baseline oral health-related quality of life at one weekone week after whiteningoral health-related quality of life measured by Oral health impact profile instrument (OHIP; scalar points, range 0-56)
change from baseline color at one weekone week after whiteningchange of color of teeth (ΔE) by spectrophotometer in scalar points (range 1-10)
change from baseline color at one yearone year after whiteningchange of color of teeth (ΔE) by spectrophotometer in scalar points (range 1-10)

Secondary

MeasureTime frameDescription
change from baseline lightness at one weekone week after whiteninglightness of teeth measured by spectrophotometer (scalar range 67-83)
change from baseline lightness at one yearone year after whiteninglightness of teeth measured by spectrophotometer (scalar range 67-83)
change from baseline chroma at one weekone week after whiteningchroma of teeth measured by spectrophotometer (range 11-25)
change from baseline chroma at one yearone year after whiteningchroma of teeth measured by spectrophotometer (range 11-25)
change from baseline translucency at one yearone year after whiteningtransluceny of teeth measured by spectrophotometer (range 0-13)
discomfort with teeth whiteningone week after whiteningdiscomfort with teeth whitening assessed by visual-analogue scale (scalar ponts 1-10)
change from baseline translucency at one weekone week after whiteningtransluceny of teeth measured by spectrophotometer (range 0-13)

Countries

Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026