Influence of Tooth Whitening on Changes in Quality of Life

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03380702
• Other study ID #: 2170-24-01-15-04
• Status: Completed
• Phase: N/A
• First received: November 22, 2017
• Last updated: December 21, 2017
• Start date: November 1, 2015
• Est. completion date: July 30, 2017

Study information

• Verified date: December 2017
• Source: University of Rijeka
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 30, 2017
• Est. primary completion date: July 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Quality of Life
• Tooth Discoloration

Intervention

Procedure:
• whitening photoactivation gel
35 subjects in active comparator group
• placebo
35 subjects in placebo comparator group

Locations

Country	Name	City	State
Croatia	Medical faculty University of Rijeka	Rijeka

Sponsors (2)

Lead Sponsor	Collaborator
Daniela Kovacevic Pavicic	University of Rijeka

Country where clinical trial is conducted

Croatia, 

References & Publications (1)

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. 2017 Oct 31. doi: 10.1111/jopr.12666. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline color at one week	change of color of teeth (?E) by spectrophotometer in scalar points (range 1-10)	one week after whitening
Primary	change from baseline color at one year	change of color of teeth (?E) by spectrophotometer in scalar points (range 1-10)	one year after whitening
Primary	change from psychosocial impact of dental aesthetics at one week	psychosocial impact of dental aesthetics measured by Psychosocial impacr of dental aesthetics questionnaire (PIDAQ; scalar points, range 0-32)	one week after whitening
Primary	change from psychosocial impact of dental aesthetics at one year	psychosocial impact of dental aesthetics measured by Psychosocial impacr of dental aesthetics questionnaire (PIDAQ; scalar points, range 0-32)	one year after whitening
Primary	change from baseline smile esthetics related quality of life at one week	smile esthetics related quality of life measured by Smile esthetics related quality of life quaetionnaire (SERQoL; scalar points, range 4-20)	one week after whitening
Primary	change from baseline smile esthetics related quality of life at one year	smile esthetics related quality of life measured by Smile esthetics related quality of life quaetionnaire (SERQoL; scalar points, range 4-20)	one year after whitening
Primary	change from baseline satisfaction with orofacial aesthetics at one week	satisfaction with orofacial aesthetics measured by Orofacial esthetic scale (OES; scalar points, range 1-45)	one week after whitening
Primary	change from baseline satisfaction with orofacial aesthetics at one year	satisfaction with orofacial aesthetics measured by Orofacial esthetic scale (OES; scalar points, range 1-45)	one year after whitening
Primary	change from baseline oral health-related quality of life at one week	oral health-related quality of life measured by Oral health impact profile instrument (OHIP; scalar points, range 0-56)	one week after whitening
Primary	change from baseline oral health-related quality of life at one year	oral health-related quality of life measured by Oral health impact profile instrument (OHIP; scalar points, range 0-56)	one year after whitening
Secondary	change from baseline lightness at one week	lightness of teeth measured by spectrophotometer (scalar range 67-83)	one week after whitening
Secondary	change from baseline lightness at one year	lightness of teeth measured by spectrophotometer (scalar range 67-83)	one year after whitening
Secondary	change from baseline chroma at one week	chroma of teeth measured by spectrophotometer (range 11-25)	one week after whitening
Secondary	change from baseline chroma at one year	chroma of teeth measured by spectrophotometer (range 11-25)	one year after whitening
Secondary	change from baseline translucency at one week	transluceny of teeth measured by spectrophotometer (range 0-13)	one week after whitening
Secondary	change from baseline translucency at one year	transluceny of teeth measured by spectrophotometer (range 0-13)	one year after whitening
Secondary	discomfort with teeth whitening	discomfort with teeth whitening assessed by visual-analogue scale (scalar ponts 1-10)	one week after whitening