A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model

Phase 3 Completed 55 enrolled GlaxoSmithKline

RandomizedCrossoverSingle-blindTreatment

Summary

An in situ model will be used to evaluate and compare enamel remineralization of human enamel specimens after single use of experimental children's toothpastes.

Timeline

Start: 2012-02
Primary completion: 2012-05
Completion: 2012-05

Outcome

Met primary endpoint

registry NaF Toothpaste (1426 Ppm F) vs Placebo Toothpaste (0 Ppm F); p <0.0001; Adjusted Mean Difference 5.59 (95% CI 3.60 to 7.58) NCT01607411 ↗

registry NaF Toothpaste (1000 Ppm F) vs Placebo Toothpaste (0 Ppm F); p <0.0001; Adjusted Mean Difference 4.36 (95% CI 2.37 to 6.35) NCT01607411 ↗

registry NaF Toothpaste (500 Ppm F) vs Placebo Toothpaste (0 Ppm F); p = 0.0021; Adjusted Mean Difference 3.16 (95% CI 1.17 to 5.15) NCT01607411 ↗

Publications

Results Newby EE, Martinez-Mier EA, Hara A, Lippert F, Kelly SA, Fleming N, Butler A, Bosma ML, Zero DT. A randomised clinical study to evaluate experimental children's toothpastes in an in-situ palatal caries model in children aged 11-14 years. Int Dent J. 2013 Dec;63 Suppl 2(Suppl 2):31-8. doi: 10.1111/idj.12073.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	sodium fluoride	Unknown	500 ppm	—
Subject	sodium fluoride	Unknown	1000 ppm	—
Subject	sodium fluoride	Unknown	1426 ppm	—