Influence of cosmetic teeth whitening on quality of life and oral health related quality of life
- Conditions
- Quality of life, oral health related quality of life, PSI, PBI, QHI
- Registration Number
- DRKS00025617
- Lead Sponsor
- Zentrum für Zahn-, Mund- und Kieferheilkunde Poliklinik für Zahnerhaltung und Parodontologie, Uniklinik Köln
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 58
Only persons of legal age will be recruited. Study participants must not have periodontitis requiring treatment and must suffer from temporary tooth sensitivity and have the desire to have their teeth whitened. Pregnant patients are excluded. (no testing)
Patients will not be included in the study despite a desire for tooth whitening if they have at least one of the following exclusion criteria:
- Participation in other interventional trials
- Allergies to any of the ingredients or contact allergies
- Medical whitening of teeth within the last 2 years
- Placement in an institution due to court or administrative order
- Age under 18 years
- Pregnancy
- Nursing mothers
- Consent is not available
- > 30 amalgam fillings
- Participation of a family member or friend living in the same household
- PSI code where more than 3 sextants were coded with a PSI code equal to or greater than 3
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PICO: The aim of this randomized, controlled, multicenter, triple-blinded clinical study is to evaluate adult patients with a desire for cosmetic tooth whitening (P) after 10-day home bleaching (I) compared with a fluoride-containing prophylaxis product (C) in terms of change in oral health and quality of life (O) over a 180-day period.<br>Methodologically, a questionnaire based on OHIP and PIDAQ surveys was created and statistically validated in the modification. In addition, established clinical parameters (PSI, PBI, QHI) are recorded to document periodontal health as well as plaque accumulation. Questionnaire and clinical parameters are collected at baseline and after adjusted baseline (professional dental cleaning) at 7, 18 and 187 days. Case number estimation yielded a sample of 32 subjects per group with a power of 80% and a significance level of 0.05.
- Secondary Outcome Measures
Name Time Method This randomized, controlled clinical study aims to examine the impact of whitened teeth on the self-esteem of study participants. The aim of the study is to show the influence of 6% H2O2 gel in the form of home bleaching on self-confidence, subjectively and objectively perceived oral health, quality of life and clinical quantifiable oral health parameters such as QHI, PSI and PBI.