In Situ Erosion Study to Investigate the Effectiveness of an Experimental Toothpaste
Summary
This will be a randomized, controlled, single center, single- blind, 3 period, 3 treatment, cross-over, in situ design which consists of placing pre-eroded bovine enamel specimens intra orally using a palatal appliance and testing the remineralizing performance of the experimental (dentifrice containing 0.254 Percent weight by weight \[%, w/w\] sodium fluoride (1150 parts per million \[ppm\] fluoride) and 5% KNO3 \[potassium nitrate\]), comparator (dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) and placebo (Fluoride free placebo containing 5% KNO3 \[0 ppm fluoride\] ) dentifrices 2 and 4 hours (hrs) post treatment application, based on surface micro hardness measurements. This study will be carried out in healthy adults with a maxillary dental arch suitable for the retention of the palatal appliance.
Timeline
- Start
- 2017-11-13
- Primary completion
- 2018-01-16
- Completion
- 2018-01-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sodium fluoride | Unknown | 0.254 % | Oral |
| Comparator | stannous fluoride | Small molecule | 0.454 % | Oral |
| Background | Potassium Nitrate | Other / unclassified | 5 % | Oral |