NCT03214406

Clinical Evaluation of the Efficacy of a Marketed Dentifrice on Plaque and Gingivitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Church & Dwight Company, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Parallel, double blind, randomized, Institutional Review Board (IRB) -approved study involving approximately 160 subjects to complete. Subjects were randomly assigned to either the test product (Arm \& Hammer Advance White Brilliant Sparkle) or the control (Crest Cavity Protection Regular) based on baseline mean whole-mouth plaque and gingival scores and age.Subjects brushed with their assigned dentifrice two times (2X) daily and were evaluated for gingivitis, bleeding and plaque at Baseline and after 4-, 8-, and 12-weeks of product use. Return to pre-study hygiene regimen for 4 weeks and final evaluation at 16 weeks.

Conditions

• Plaque
• Gingivitis

Interventions

Type	Name	Description
DRUG	Arm & Hammer Advance White Brilliant Sparkle (Test product)	20% sodium bicarbonate
DRUG	Crest Cavity Protection Regular Toothpaste (Negative Control)	Negative control

Timeline

• Start date: 2010-02-08
• Primary completion: 2010-08-03
• Completion: 2010-08-03
• First posted: 2017-07-11
• Last updated: 2021-05-11
• Results posted: 2019-07-23

Locations

1 site across 1 country: Canada