Influence of Tooth Whitening on Changes in Quality of Life
NCT ID: NCT03380702
Last Updated: 2017-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2015-11-01
2017-07-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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whitening photoactivation gel
exposure to hydrogen gel and photoactivation for teeth whitening
whitening photoactivation gel
35 subjects in active comparator group
placebo
exposure to gel without active whitening substance and the same photoactivation source as active comparator
placebo
35 subjects in placebo comparator group
Interventions
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whitening photoactivation gel
35 subjects in active comparator group
placebo
35 subjects in placebo comparator group
Eligibility Criteria
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Inclusion Criteria
* anterior tooth segment free of fillings
* anterior tooth segment free of prosthetic restorations
Exclusion Criteria
* Malocclusion present (Index of Orthodontic Treatment Need-Dental Health Component ≤3 and Aesthetic Component ≤4)
18 Years
30 Years
ALL
Yes
Sponsors
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University of Rijeka
OTHER
Daniela Kovacevic Pavicic
OTHER
Responsible Party
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Daniela Kovacevic Pavicic
professor
Locations
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Medical faculty University of Rijeka
Rijeka, , Croatia
Countries
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References
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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.
Batinic M, Kovacevic Pavicic D, Sango A, Brumini M, Spalj S. Effect of personality characteristics on perception of tooth whitening outcome in young adults in long-term: a randomised, double-blind, placebo controlled trial. Head Face Med. 2025 Aug 7;21(1):57. doi: 10.1186/s13005-025-00536-3.
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.
Other Identifiers
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2170-24-01-15-04
Identifier Type: -
Identifier Source: org_study_id