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

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).

Study Overview

• Status: Completed
• Conditions: Quality of Life; Tooth Discoloration
• Intervention / Treatment: Procedure: whitening photoactivation gel; Procedure: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Rijeka, Croatia, 51000
    • Medical faculty University of Rijeka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: whitening photoactivation gel; exposure to hydrogen gel and photoactivation for teeth whitening	Procedure: whitening photoactivation gel; 35 subjects in active comparator group
PLACEBO_COMPARATOR: placebo; exposure to gel without active whitening substance and the same photoactivation source as active comparator	Procedure: placebo; 35 subjects in placebo comparator group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline color at one week	change of color of teeth (ΔE) by spectrophotometer in scalar points (range 1-10)	one week after whitening
change from baseline color at one year	change of color of teeth (ΔE) by spectrophotometer in scalar points (range 1-10)	one year after whitening
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline lightness at one week	lightness of teeth measured by spectrophotometer (scalar range 67-83)	one week after whitening
change from baseline lightness at one year	lightness of teeth measured by spectrophotometer (scalar range 67-83)	one year after whitening
change from baseline chroma at one week	chroma of teeth measured by spectrophotometer (range 11-25)	one week after whitening
change from baseline chroma at one year	chroma of teeth measured by spectrophotometer (range 11-25)	one year after whitening
change from baseline translucency at one week	transluceny of teeth measured by spectrophotometer (range 0-13)	one week after whitening
change from baseline translucency at one year	transluceny of teeth measured by spectrophotometer (range 0-13)	one year after whitening
discomfort with teeth whitening	discomfort with teeth whitening assessed by visual-analogue scale (scalar ponts 1-10)	one week after whitening

Collaborators and Investigators

• Sponsor: Daniela Kovacevic Pavicic
• Collaborators: University of Rijeka

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2015
• Primary Completion (ACTUAL): July 30, 2016
• Study Completion (ACTUAL): July 30, 2017

Study Registration Dates

• First Submitted: November 22, 2017
• First Submitted That Met QC Criteria: December 16, 2017
• First Posted (ACTUAL): December 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 21, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: quality of life; colour; dental aesthetics; perceptions; tooth whitening
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Discoloration
• Other Study ID Numbers: 2170-24-01-15-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The publication of scientific manuscript.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No