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Influence of Tooth Whitening on Changes in Quality of Life

Primary Purpose

Tooth Discoloration, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
whitening photoactivation gel
placebo
Sponsored by
Daniela Kovacevic Pavicic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Discoloration focused on measuring colour, dental aesthetics, perceptions, quality of life, tooth whitening

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts 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)

Sites / Locations

  • Medical faculty University of Rijeka

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

whitening photoactivation gel

placebo

Arm Description

exposure to hydrogen gel and photoactivation for teeth whitening

exposure to gel without active whitening substance and the same photoactivation source as active comparator

Outcomes

Primary Outcome Measures

change from baseline color at one week
change of color of teeth (ΔE) by spectrophotometer in scalar points (range 1-10)
change from baseline color at one year
change of color of teeth (ΔE) by spectrophotometer in scalar points (range 1-10)
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)
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)
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)
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)
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)
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)
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)
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)

Secondary Outcome Measures

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

Full Information

First Posted
November 22, 2017
Last Updated
December 21, 2017
Sponsor
Daniela Kovacevic Pavicic
Collaborators
University of Rijeka
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1. Study Identification

Unique Protocol Identification Number
NCT03380702
Brief Title
Influence of Tooth Whitening on Changes in Quality of Life
Official Title
Influence of Tooth Whitening on Changes in Quality of Life: a Randomized Double-blinded Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2015 (Actual)
Primary Completion Date
July 30, 2016 (Actual)
Study Completion Date
July 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniela Kovacevic Pavicic
Collaborators
University of Rijeka

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Discoloration, Quality of Life
Keywords
colour, dental aesthetics, perceptions, quality of life, tooth whitening

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RANDOMIZED DOUBLE-BLINDED PLACEBO-CONTROLLED TRIAL
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
whitening photoactivation gel
Arm Type
Active Comparator
Arm Description
exposure to hydrogen gel and photoactivation for teeth whitening
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
exposure to gel without active whitening substance and the same photoactivation source as active comparator
Intervention Type
Procedure
Intervention Name(s)
whitening photoactivation gel
Intervention Description
35 subjects in active comparator group
Intervention Type
Procedure
Intervention Name(s)
placebo
Intervention Description
35 subjects in placebo comparator group
Primary Outcome Measure Information:
Title
change from baseline color at one week
Description
change of color of teeth (ΔE) by spectrophotometer in scalar points (range 1-10)
Time Frame
one week after whitening
Title
change from baseline color at one year
Description
change of color of teeth (ΔE) by spectrophotometer in scalar points (range 1-10)
Time Frame
one year after whitening
Title
change from psychosocial impact of dental aesthetics at one week
Description
psychosocial impact of dental aesthetics measured by Psychosocial impacr of dental aesthetics questionnaire (PIDAQ; scalar points, range 0-32)
Time Frame
one week after whitening
Title
change from psychosocial impact of dental aesthetics at one year
Description
psychosocial impact of dental aesthetics measured by Psychosocial impacr of dental aesthetics questionnaire (PIDAQ; scalar points, range 0-32)
Time Frame
one year after whitening
Title
change from baseline smile esthetics related quality of life at one week
Description
smile esthetics related quality of life measured by Smile esthetics related quality of life quaetionnaire (SERQoL; scalar points, range 4-20)
Time Frame
one week after whitening
Title
change from baseline smile esthetics related quality of life at one year
Description
smile esthetics related quality of life measured by Smile esthetics related quality of life quaetionnaire (SERQoL; scalar points, range 4-20)
Time Frame
one year after whitening
Title
change from baseline satisfaction with orofacial aesthetics at one week
Description
satisfaction with orofacial aesthetics measured by Orofacial esthetic scale (OES; scalar points, range 1-45)
Time Frame
one week after whitening
Title
change from baseline satisfaction with orofacial aesthetics at one year
Description
satisfaction with orofacial aesthetics measured by Orofacial esthetic scale (OES; scalar points, range 1-45)
Time Frame
one year after whitening
Title
change from baseline oral health-related quality of life at one week
Description
oral health-related quality of life measured by Oral health impact profile instrument (OHIP; scalar points, range 0-56)
Time Frame
one week after whitening
Title
change from baseline oral health-related quality of life at one year
Description
oral health-related quality of life measured by Oral health impact profile instrument (OHIP; scalar points, range 0-56)
Time Frame
one year after whitening
Secondary Outcome Measure Information:
Title
change from baseline lightness at one week
Description
lightness of teeth measured by spectrophotometer (scalar range 67-83)
Time Frame
one week after whitening
Title
change from baseline lightness at one year
Description
lightness of teeth measured by spectrophotometer (scalar range 67-83)
Time Frame
one year after whitening
Title
change from baseline chroma at one week
Description
chroma of teeth measured by spectrophotometer (range 11-25)
Time Frame
one week after whitening
Title
change from baseline chroma at one year
Description
chroma of teeth measured by spectrophotometer (range 11-25)
Time Frame
one year after whitening
Title
change from baseline translucency at one week
Description
transluceny of teeth measured by spectrophotometer (range 0-13)
Time Frame
one week after whitening
Title
change from baseline translucency at one year
Description
transluceny of teeth measured by spectrophotometer (range 0-13)
Time Frame
one year after whitening
Title
discomfort with teeth whitening
Description
discomfort with teeth whitening assessed by visual-analogue scale (scalar ponts 1-10)
Time Frame
one week after whitening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Medical faculty University of Rijeka
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The publication of scientific manuscript.
Citations:
PubMed Identifier
29086473
Citation
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.
Results Reference
background
PubMed Identifier
31289971
Citation
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.
Results Reference
derived

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Influence of Tooth Whitening on Changes in Quality of Life

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