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

PHASE3CompletedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

November 13, 2017

Primary Completion Date

January 16, 2018

Study Completion Date

January 16, 2018

Conditions
Tooth Erosion
Interventions
DRUG

0.254% w/w sodium fluoride and 5% KNO3

Dentifrice containing 0.254% w/w sodium fluoride (1150 ppm fluoride) and 5% KNO3; plus 0.25% PVM/MA copolymer and 2.5% sodium lactate. Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 millilitres \[mL\] of tap water for 10 seconds before expectorating again.

DRUG

0.454% w/w stannous fluoride

Dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 mL of tap water for 10 seconds before expectorating again.

DRUG

5% KNO3

Fluoride free placebo dentifrice containing 5% KNO3 (0 ppm fluoride), 0.25% PVM/MA copolymer and 2.5% lactate. Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 mL of tap water for 10 seconds before expectorating again.

Trial Locations (1)

46202

GSK Investigational Site, Indianapolis

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03296072 - In Situ Erosion Study to Investigate the Effectiveness of an Experimental Toothpaste | Biotech Hunter | Biotech Hunter