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Influence of Tooth Whitening on Changes in Quality of Life

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03380702
Recruitment Status : Completed
First Posted : December 21, 2017
Last Update Posted : December 26, 2017
Sponsor:
Collaborator:
University of Rijeka
Information provided by (Responsible Party):
Daniela Kovacevic Pavicic, University of Rijeka

Study Description
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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).


Condition or disease Intervention/treatment Phase
Tooth Discoloration Quality of Life Procedure: whitening photoactivation gel Procedure: placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RANDOMIZED DOUBLE-BLINDED PLACEBO-CONTROLLED TRIAL
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Influence of Tooth Whitening on Changes in Quality of Life: a Randomized Double-blinded Placebo-controlled Trial
Actual Study Start Date : November 1, 2015
Actual Primary Completion Date : July 30, 2016
Actual Study Completion Date : July 30, 2017
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380702


Locations
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Croatia
Medical faculty University of Rijeka
Rijeka, Croatia, 51000
Sponsors and Collaborators
Daniela Kovacevic Pavicic
University of Rijeka
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Daniela Kovacevic Pavicic, professor, University of Rijeka
ClinicalTrials.gov Identifier: NCT03380702    
Other Study ID Numbers: 2170-24-01-15-04
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The publication of scientific manuscript.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniela Kovacevic Pavicic, University of Rijeka:
colour
dental aesthetics
perceptions
quality of life
tooth whitening
Additional relevant MeSH terms:
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Tooth Discoloration
Tooth Diseases
Stomatognathic Diseases