NCT02207907

To Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste

A Six Month Clinical Study Based in the US to Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary objectives of this study will be to compare the Gingival Bleeding and Gingival Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate toothpaste after 24 weeks of use. The study will be conducted at Silverstone Research Group. Participants will be recruited from their database and by use of an external recruitment agency.

Conditions

• Oral Hygiene

Interventions

Type	Name	Description
DRUG	Sodium bicarbonate plus sodium fluoride	Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
DRUG	Sodium fluoride	Toothpaste containing 1100 ppm fluoride as sodium fluoride

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-02-01
• Completion: 2015-03-01
• First posted: 2014-08-04
• Last updated: 2017-04-13
• Results posted: 2017-02-17

Locations

1 site across 1 country: United States