Tooth DiscolorationNCT03380702
Influence of Tooth Whitening on Changes in Quality of Life
A study testing whitening photoactivation gel in people with Tooth Discoloration and Quality of Life, run by Daniela Kovacevic Pavicic at 1 site in Croatia.
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration, Quality of Life
- What is being tested?
- whitening photoactivation gel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Nov 2015to 30 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- presence of a complete anterior tooth segment free of caries
- anterior tooth segment free of fillings
- anterior tooth segment free of prosthetic restorations
Who cannot join
- Gingivitis present
- Malocclusion present (Index of Orthodontic Treatment Need-Dental Health Component ≤3 and Aesthetic Component ≤4)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Tooth Discoloration, Quality of Life
- Being tested
- whitening photoactivation gel, placebo
- Keywords
- colour, dental aesthetics, perceptions, quality of life, tooth whitening
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whitening photoactivation gelProcedure or surgery
35 subjects in active comparator group
placeboProcedure or surgery
35 subjects in placebo comparator group
| Study group | Role | What they receive |
|---|---|---|
| whitening photoactivation gel | Active comparator | exposure to hydrogen gel and photoactivation for teeth whitening Receives: Procedure: whitening photoactivation gel |
| placebo | Placebo comparator | exposure to gel without active whitening substance and the same photoactivation source as active comparator Receives: Procedure: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline color at one week
change of color of teeth (ΔE) by spectrophotometer in scalar points (range 1-10)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: one year after whitening
Secondary outcomes (7)
change from baseline lightness at one week
lightness of teeth measured by spectrophotometer (scalar range 67-83)
Measured: one week after whitening
change from baseline lightness at one year
lightness of teeth measured by spectrophotometer (scalar range 67-83)
Measured: one year after whitening
change from baseline chroma at one week
chroma of teeth measured by spectrophotometer (range 11-25)
Measured: one week after whitening
change from baseline chroma at one year
chroma of teeth measured by spectrophotometer (range 11-25)
Measured: one year after whitening
change from baseline translucency at one week
transluceny of teeth measured by spectrophotometer (range 0-13)
Measured: one week after whitening
change from baseline translucency at one year
transluceny of teeth measured by spectrophotometer (range 0-13)
Measured: one year after whitening
discomfort with teeth whitening
discomfort with teeth whitening assessed by visual-analogue scale (scalar ponts 1-10)
Measured: one week after whitening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start1 Nov 2015
- Primary completion30 Jul 2016
- Study completion30 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tooth DiscolorationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RANDOMIZED DOUBLE-BLINDED PLACEBO-CONTROLLED TRIAL
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniela Kovacevic Pavicic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rijeka
- Responsible party
- Sponsor-investigator, Daniela Kovacevic Pavicic, University of Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380702
- Sponsor's protocol ID
- 2170-24-01-15-04
- Status last verified
- Dec 2017
- First submitted
- 22 Nov 2017
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The publication of scientific manuscript.
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.
PubMed 29086473Kos M, Kolceg Batinic M, Kiseri Kubati J, Kovacevic Pavicic D, Spalj S. Perception of Long-Term Changes in Smile Aesthetics Following Dental Bleaching: A Randomized Controlled Trial. Int J Dent Hyg. 2026 Aug 10. doi: 10.1111/idh.70146. Online ahead of print.
PubMed 42576255Batinic 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.
PubMed 40775639Kovacevic 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.
PubMed 31289971
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Tooth Whitening on Changes in Quality of Life: a Randomized Double-blinded Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03380702
- Acronym / sponsor ID
- 2170-24-01-15-04
- Conditions
- Tooth Discoloration, Quality of Life
- Keywords
- colour, dental aesthetics, perceptions, quality of life, tooth whitening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Daniela Kovacevic PavicicUniversity, hospital or other
- Collaborators
- University of Rijeka
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 30 Jul 2016 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 21 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- RANDOMIZED DOUBLE-BLINDED PLACEBO-CONTROLLED TRIAL
| Arm | Type | Receives |
|---|---|---|
| whitening photoactivation gel | Active comparator | Procedure: whitening photoactivation gelexposure to hydrogen gel and photoactivation for teeth whitening |
| placebo | Placebo comparator | Procedure: placeboexposure to gel without active whitening substance and the same photoactivation source as active comparator |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- presence of a complete anterior tooth segment free of caries
- anterior tooth segment free of fillings
- anterior tooth segment free of prosthetic restorations
Key exclusion criteria (2 listed)
- Gingivitis present
- Malocclusion present (Index of Orthodontic Treatment Need-Dental Health Component ≤3 and Aesthetic Component ≤4)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whitening photoactivation gel35 subjects in active comparator group | Procedure or surgery | whitening photoactivation gel |
| placebo35 subjects in placebo comparator group | Procedure or surgery | placebo |
Primary outcome
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
7 secondary outcomes
change from baseline lightness at one week
Time frame: one week after whitening
change from baseline lightness at one year
Time frame: one year after whitening
change from baseline chroma at one week
Time frame: one week after whitening
change from baseline chroma at one year
Time frame: one year after whitening
change from baseline translucency at one week
Time frame: one week after whitening
change from baseline translucency at one year
Time frame: one year after whitening
discomfort with teeth whitening
Time frame: one week after whitening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Background: PubMed 29086473Kovacevic 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.
- Derived from this study: PubMed 42576255Kos M, Kolceg Batinic M, Kiseri Kubati J, Kovacevic Pavicic D, Spalj S. Perception of Long-Term Changes in Smile Aesthetics Following Dental Bleaching: A Randomized Controlled Trial. Int J Dent Hyg. 2026 Aug 10. doi: 10.1111/idh.70146. Online ahead of print.
- Derived from this study: PubMed 40775639Batinic 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.
- Derived from this study: PubMed 31289971Kovacevic 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.
- Individual participant dataSharing planned: No. The publication of scientific manuscript.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whitening photoactivation gel in people with Tooth Discoloration and Quality of Life, run by Daniela Kovacevic Pavicic at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline color at one week (time frame: one week after whitening). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03380702, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.