Phase 3 N=55 Randomized Single-blind Treatment

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

Dental Caries

Bottom Line

View on ClinicalTrials.gov: NCT01607411 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2013

Primary outcome: Primary: Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice — 30.72; 29.49; 28.29; 25.13 %SMHR — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Fluoride (Drug); Placebo (Drug)
Age: Pediatric · 11+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice	30.72; 29.49; 28.29; 25.13	<0.0001 sig
SECONDARY %SMHR of Enamel Specimens Exposed to Test Treatments	30.72; 29.49; 28.29	0.2225
SECONDARY Percent Net Acid Resistance (%NAR) of Enamel Specimens	-19.72; -19.52; -25.82; -54.38	<0.0001 sig
SECONDARY Enamel Fluoride Uptake	1.76; 1.77; 1.47; 0.98	<0.0001 sig

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.

Eligibility Criteria

Inclusion Criteria

Healthy males and females aged 11 to 14 inclusive who have an unstimulated salivary flow rate of at least 0.2 mL/minute and a stimulated salivary flow rate of at least 0.8 mL/minute (Screening Visit 1).

Exclusion Criteria

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Data sourced from ClinicalTrials.gov (NCT01607411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.