To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms

Summary

This study will 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 Salus Research, Inc. Participants will be recruited from their database and by use of an external recruitment agency

Timeline

Start

2014-08-25

Primary completion

2015-02-01

Completion

2015-04-30

Outcome

Met primary endpoint

registry analysis (superiority or other test); Sodium Bicarbonate and Sodium Fluoride Dentifrice vs Sodium Fluoride Dentifrice; p <0.0001; Adjusted Mean Difference -11.612 (95% CI -13.191 to -10.033); ANCOVA NCT02207400 ↗

registry analysis (superiority or other test); Sodium Bicarbonate and Sodium Fluoride Dentifrice vs Sodium Fluoride Dentifrice; p <0.0001; Adjusted mean difference -0.652 (95% CI -0.738 to -0.566); ANCOVA NCT02207400 ↗

Publications

• Jose A, Pratten J, Bosma ML, Milleman KR, Milleman JL, Wang N. Six-Month Evaluation of a Sodium Bicarbonate-Containing Toothpaste for Reduction of Established Gingivitis: A Randomized USA-Based Clinical Trial. J Clin Dent. 2018 Mar;29(1):33-39.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	sodium bicarbonate	Diagnostic / imaging agent	67 %	—
Subject	sodium fluoride	Unknown	1100 ppm	—
Subject	sodium fluoride	Unknown	1150 ppm	—

Indications

No indication recorded.