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Influence of Tooth Whitening on Changes in Quality of Life

D

Daniela Kovacevic Pavicic

Status

Completed

Conditions

Tooth Discoloration
Quality of Life

Treatments

Procedure: whitening photoactivation gel
Procedure: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03380702
2170-24-01-15-04

Details and patient eligibility

About

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).

Full 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.

Enrollment

70 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

70 participants in 2 patient groups, including a placebo group

whitening photoactivation gel
Active Comparator group
Description:
exposure to hydrogen gel and photoactivation for teeth whitening
Treatment:
Procedure: whitening photoactivation gel
placebo
Placebo Comparator group
Description:
exposure to gel without active whitening substance and the same photoactivation source as active comparator
Treatment:
Procedure: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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