Clinical Trial: A Study to Investigate the Antimicrobial Activity of 2 Test Toothpastes
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Study to Investigate the Antimicrobial Activity of Two Test Toothpastes in a Plaque Glycolysis and Regrowth Model
Brief Summary: The aim of this exploratory study is to assess the ability of two test toothpastes containing 0.6% w/w zinc chloride stabilised with sodium citrate in a sodium lauryl sulfate (SLS)-containing base to reduce glycolytic metabolism and viability of de novo plaque bacteria using the plaque glycolysis regrowth model (PGRM).
Detailed Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome: Area Under the Curve for Glycolysis (AUCgly(0-90)) of Test Zinc-IPMP and Non-SLS Negative Control [ Time Frame: Baseline up to 90 minutes (min) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- AUCgly(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control [ Time Frame: Baseline up to 90 min ]AUCgly(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control was calculated using trapezoidal method.
- AUCregrowth(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control [ Time Frame: Baseline up to 90 min ]AUCregrowth(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control was calculated using trapezoidal method.
- AUClive:Dead(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control [ Time Frame: Baseline up to 90 min ]AUClive:dead(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control was calculated using trapezoidal method.
Original Secondary Outcome: Same as current
Information By: GlaxoSmithKline
Dates:
Date Received: June 6, 2016
Date Started: October 2015
Date Completion:
Last Updated: January 12, 2017
Last Verified: January 2017