drugset / Trial / NCT03296072

In Situ Erosion Study to Investigate the Effectiveness of an Experimental Toothpaste

NCT03296072

Phase 3 Completed 62 enrolled GlaxoSmithKline
RandomizedCrossoverDouble-blindTreatment

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

EvaluationDrugModalityDoseRoute
Subject sodium fluoride Unknown 0.254 % Oral
Comparator stannous fluoride Small molecule 0.454 % Oral
Background Potassium Nitrate Other / unclassified 5 % Oral