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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 3

Conditions

Dental Caries

Treatments

Drug: Placebo
Drug: Fluoride

Study type

Interventional

Funder types

Industry

Identifiers

NCT01607411
RH01390

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Ages

11 to 14 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

55 participants in 4 patient groups, including a placebo group

Fluoride free toothpaste
Placebo Comparator group
Description:
toothpaste with no fluoride
Treatment:
Drug: Placebo
1426ppm Fluoride Toothpaste
Experimental group
Description:
Experimental toothpaste containing 1426 ppm Fluoride
Treatment:
Drug: Fluoride
1000 ppm Fluoride Toothpaste
Experimental group
Description:
Experimental toothpaste containing 1000 ppm Fluoride
Treatment:
Drug: Fluoride
500 ppm Toothpaste
Experimental group
Description:
Experimental toothpaste containing 500 ppm Fluoride
Treatment:
Drug: Fluoride

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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