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"Stain", Clinical Study Agreement Procter & Gamble 2017166

Laufzeit: 01.01.2017 - 31.12.2022

Kurzfassung


This is a single-center, unsupervised use, single-treatment study. The study will consist of an up-to 3-week stain induction phase followed by a 3-week treatment (stain removal) phase.
A sufficient number of subjects will be screened to obtain approximately 35 adult volunteers to enroll in the study and begin the 3-week run-in phase. Subjects with existing natural tooth stain will receive an optional dental prophylaxis at the beginning of the study, and will be assigned an acclimation...
This is a single-center, unsupervised use, single-treatment study. The study will consist of an up-to 3-week stain induction phase followed by a 3-week treatment (stain removal) phase.
A sufficient number of subjects will be screened to obtain approximately 35 adult volunteers to enroll in the study and begin the 3-week run-in phase. Subjects with existing natural tooth stain will receive an optional dental prophylaxis at the beginning of the study, and will be assigned an acclimation toothbrush and toothpaste, and will rinse with tea solution three times daily and with a chlorhexidine rinse (0.1%) once daily for up to three weeks during the run-in phase.
After the run-in phase, up to 30 qualified subjects (with visible stains on anterior teeth) will continue the study and receive treatment products (whitening toothpaste and regular manual toothbrush) to use twice daily for the 3 weeks treatment phase. Tooth color measurements using DIA will be assessed after stain induction (Baseline) and after 3 weeks of treatment (Week 3). Clinical documentary images will be taken at Baseline and Week 3 visits. Subjects will receive a refresher on their oral hygien e instructions at Visit 4 (Week 1).
 
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