Cosmetic application for tooth whitening
Conditions
Interventions
Group 1: Application of Curolox Technology plus calcium phosphate: 1. Application on D0 done by the investiagor/study team
Between D1 and D7 home application of Curolox Technology plus calcium phosphate.
Sponsors
credentis ag
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1 Age = 18 years and = 75 years 2 Patients with sound maxillary canines and incisors: - Caries-free (buccal) - No erosion - No partial restorations (buccal) 3 At least one tooth with tooth colour of A3 or darker assessed by VITA EasyShade Note: VITA Classic Tooth Colour arrangement according to brightness values: B1, A1, B2, D2, A2, C1, C2, D4, A3, D3, B3, A3.5, B4, C3, A4, C4 4 Willing and able to understand all study-related procedures and to follow the treatment instructions 5 Willing and able to attend the on-study visits and assessments 6 Written informed consent before participation in the study
Exclusion criteria
Exclusion criteria: 1 Subjects with general tooth hypersensitivity on sugar 2 Subjects with poor oral hygiene 3 Subjects with fluorosis on study teeth 4 Concurrent participation in another clinical trial 5 Bleaching during this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy outcome is the difference in tooth colour (?E) as calculated from the data obtained from VITA Easyshade from baseline D0 to 1 day after treatment (D1) with the investigational product. The primary safety endpoint is percentage and distribution of severity of Undesirable Effects and Serious Undesirable Effects related to the investigational product. | — |
Secondary
| Measure | Time frame |
|---|---|
| • The difference in tooth colour (?E) as calculated by VITA Easyshade from baseline (D0) to just after the 1th treatment (D0t), to D7, D30 of treatment with the investigational product. • The change in colour class (A1-C4) assessed by VITA Easyshade from baseline (D0) to just after the 1th treatment (D0t), to D1, D7, D30 of treatment with the investigational product. • The change in tooth brightness visually assessed by VITA Bleaching Masterguide from baseline (D0) to just after the 1th treatment (D0t), to D1, D7, D30 of treatment with the investigational product. • Subject’s satisfaction about product assessed by questionnaire from baseline (D0) to just after the 1th treatment (D0t), to D1, D7, D30 of treatment with the investigational product. | — |
Countries
Germany
Contacts
Public ContactHans-Peter Flessa
Gemeinschaftspraxis für Zahnheilkunde
Outcome results
None listed