extrinsic tooth discoloration K03.6
Conditions
Interventions
Group 1: active agent - 20 subjects get a treatment for 20 minutes with ready-to-use trays and an OTC bleaching agent. Lower und upper jaw are both treated. The gel contains of pthalimidocaproic acid
Sponsors
Sylphar NV
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: • 12 natural, frontal teeth • tooth color darker than A2 of the Vita-Shade-Guide
Exclusion criteria
Exclusion criteria: • acute disease • alcoholism • smoker • allergy • pregnant/nursing • acute ginivitis, gingivostomatitis, reduced immunesystem caused by disease (eg HIV) • orthodontic • hypersensitive teeth or exposed dentin tubuli • pathological or defect enamel structure • extensive fillings or crowns on frontal teeth • bleaching
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shade improvement of the examined teeth directly after single use treatment with the OTC bleaching agent in comparison to the placebo with the Vita-Shade-Guide. | — |
Secondary
| Measure | Time frame |
|---|---|
| Shade improvement of the examined teeth 24 hours after the treatment in comparison to the placebo with a Vita-Shade-Guide. No tooth sensitivities or muscosairritations directly or after 24 hour after treatment. The sensibilities are assessed using coolant spray and physiological feedback of the subject. Hypersensibilities after the treatment are assessed in comparison to baseline measurements. The mucosa is visually clinical examined by the investigator and irritations and/or ulcerations protocolled. The good acceptance is assessed by an individual (PI) made questionaire "subject questionaire", filled out by the subjects on the last visit. | — |
Countries
Germany
Contacts
Public ContactJulia Domin
Universität Witten/HerdeckeFakultät GesundheitDepartement für Zahnerhaltung und präventive Zahnmedizin
Outcome results
None listed