Who is sponsoring NCT01641237?

NCT01641237 is sponsored by GlaxoSmithKline.

What condition does NCT01641237 study?

NCT01641237 studies Enamel Erosion.

What drugs are being tested in NCT01641237?

Interventions: sodium fluoride, no added fluoride in a silica base.

What is the status of NCT01641237?

NCT01641237 is currently COMPLETED.

Last reviewed 2014-07-17 · How we verify

The Effect of Fluoride in an Experimental Dentifrice on Remineralization of Erosive Lesions In-Situ

NCT01641237 Phase 3 COMPLETED Results posted

The proposed study will evaluate the performance of fluoride delivered from a new dentifrice formulation without potassium nitrate. It will also evaluate the dose-response to fluoride by testing four dentifrices covering a range of sodium fluoride concentration.

Details

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	COMPLETED
Enrolment	72
Start date	2012-03
Completion	2012-05

Conditions

Enamel Erosion

Interventions

sodium fluoride
no added fluoride in a silica base

Primary outcomes

Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship — Baseline to 4 hours
SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: \[(E1-R)/ (E1-B)\]\*100.

Countries

United States