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Completed

NCT Number: NCT03380702

Influence of Tooth Whitening on Changes in Quality of Life

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).

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Key information

Conditions

Tooth Discoloration Quality of Life Stomatognathic Diseases Tooth Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical faculty University of Rijeka

Rijeka, 51000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

whitening photoactivation gel

Procedure

35 subjects in active comparator group

Placebo

Procedure

35 subjects in placebo comparator group

Primary outcomes

  1. change from baseline color at one week

    Time frame: one week after whitening

    change of color of teeth (ΔE) by spectrophotometer in scalar points (range 1-10)

  2. change from baseline color at one year

    Time frame: one year after whitening

    change of color of teeth (ΔE) by spectrophotometer in scalar points (range 1-10)

  3. change from psychosocial impact of dental aesthetics at one week

    Time frame: one week after whitening

    psychosocial impact of dental aesthetics measured by Psychosocial impacr of dental aesthetics questionnaire (PIDAQ; scalar points, range 0-32)

  4. change from psychosocial impact of dental aesthetics at one year

    Time frame: one year after whitening

    psychosocial impact of dental aesthetics measured by Psychosocial impacr of dental aesthetics questionnaire (PIDAQ; scalar points, range 0-32)

  5. change from baseline smile esthetics related quality of life at one week

    Time frame: 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)

  6. change from baseline smile esthetics related quality of life at one year

    Time frame: 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)

  7. change from baseline satisfaction with orofacial aesthetics at one week

    Time frame: one week after whitening

    satisfaction with orofacial aesthetics measured by Orofacial esthetic scale (OES; scalar points, range 1-45)

  8. change from baseline satisfaction with orofacial aesthetics at one year

    Time frame: one year after whitening

    satisfaction with orofacial aesthetics measured by Orofacial esthetic scale (OES; scalar points, range 1-45)

  9. change from baseline oral health-related quality of life at one week

    Time frame: one week after whitening

    oral health-related quality of life measured by Oral health impact profile instrument (OHIP; scalar points, range 0-56)

  10. change from baseline oral health-related quality of life at one year

    Time frame: one year after whitening

    oral health-related quality of life measured by Oral health impact profile instrument (OHIP; scalar points, range 0-56)

Secondary outcomes

  1. change from baseline lightness at one week

    Time frame: one week after whitening

    lightness of teeth measured by spectrophotometer (scalar range 67-83)

  2. change from baseline lightness at one year

    Time frame: one year after whitening

    lightness of teeth measured by spectrophotometer (scalar range 67-83)

  3. change from baseline chroma at one week

    Time frame: one week after whitening

    chroma of teeth measured by spectrophotometer (range 11-25)

  4. change from baseline chroma at one year

    Time frame: one year after whitening

    chroma of teeth measured by spectrophotometer (range 11-25)

  5. change from baseline translucency at one week

    Time frame: one week after whitening

    transluceny of teeth measured by spectrophotometer (range 0-13)

  6. change from baseline translucency at one year

    Time frame: one year after whitening

    transluceny of teeth measured by spectrophotometer (range 0-13)

  7. discomfort with teeth whitening

    Time frame: one week after whitening

    discomfort with teeth whitening assessed by visual-analogue scale (scalar ponts 1-10)

Sponsors and collaborators

Lead sponsor

Daniela Kovacevic Pavicic

Other

Collaborators

  • University of Rijeka

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Dec 21, 2017
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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