To Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste

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.

Timeline

Start

2014-08

Primary completion

2015-02

Completion

2015-03

Outcome

Met primary endpoint

registry analysis (superiority or other test); Sodium Bicarbonate Dentrifice vs 0% Sodium Bicarbonate Dentrifice; p <0.0001; Adjusted Mean Difference -17.491 (95% CI -20.317 to -14.664); ANCOVA NCT02207907 ↗

registry analysis (superiority or other test); Sodium Bicarbonate Dentrifice vs 0% Sodium Bicarbonate Dentrifice; p <0.0001; Adjusted Mean Difference -0.201 (95% CI -0.237 to -0.165); ANCOVA NCT02207907 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	sodium bicarbonate	Diagnostic / imaging agent	—	—
Subject	sodium fluoride	Unknown	1100 ppm	—
Subject	sodium fluoride	Unknown	1150 ppm	—

Indications

No indication recorded.