Quality of life, oral health related quality of life, PSI, PBI, QHI
Conditions
Interventions
Group 1: The test product Opalescence Go 6% Mint is a cosmetic product. It is a home bleaching gel in ready-made, customizable application trays which, like the control product, are available in green
Sponsors
Zentrum für Zahn-, Mund- und Kieferheilkunde Poliklinik für Zahnerhaltung und Parodontologie, Uniklinik Köln
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactJianna Zeiger
Zentrum für Zahn-, Mund- und Kieferheilkunde Poliklinik für Zahnerhaltung und Parodontologie, Uniklinik Köln
Outcome results
None listed