Influence of Tooth Whitening on Changes in Quality of Life

NCT03380702 | Completed

• 1 other identifier: 2170-24-01-15-04
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Tooth Discoloration; Quality of Life

Keywords

colour; dental aesthetics; perceptions; quality of life; tooth whitening

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (7)

• change from baseline lightness at one week

  one week after whitening

• change from baseline lightness at one year

  one year after whitening

• change from baseline chroma at one week

  one week after whitening

• change from baseline chroma at one year

  one year after whitening

• change from baseline translucency at one week

  one week after whitening

Study Arms (2)

whitening photoactivation gel

ACTIVE COMPARATOR

exposure to hydrogen gel and photoactivation for teeth whitening

Procedure: whitening photoactivation gel

placebo

PLACEBO COMPARATOR

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

Procedure: placebo

Interventions

whitening photoactivation gel PROCEDURE

35 subjects in active comparator group

whitening photoactivation gel

placebo PROCEDURE

35 subjects in placebo comparator group

placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• presence of a complete anterior tooth segment free of caries
• anterior tooth segment free of fillings
• anterior tooth segment free of prosthetic restorations

You may not qualify if:

• Gingivitis present
• Malocclusion present (Index of Orthodontic Treatment Need-Dental Health Component ≤3 and Aesthetic Component ≤4)

Sponsors & Collaborators

• Daniela Kovacevic Pavicic: lead
• University of Rijeka: collaborator

Study Sites (1)

Medical faculty University of Rijeka

Rijeka, 51000, Croatia

Location

Related Publications (3)

• 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.

  PMID: 29086473 BACKGROUND

• 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.

  PMID: 40775639 DERIVED

• 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.

  PMID: 31289971 DERIVED

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Model Details: RANDOMIZED DOUBLE-BLINDED PLACEBO-CONTROLLED TRIAL

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 21, 2017
• Study Start: November 1, 2015
• Primary Completion: July 30, 2016
• Study Completion: July 30, 2017
• Last Updated: December 26, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)