A Study to Investigate the Antimicrobial Activity of Two Test Toothpastes in a Plaque Glycolysis and Regrowth Model

GlaxoSmithKline1 site in 1 country45 target enrollmentNovember 9, 2015

ConditionsDental Plaque

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dental Plaque
Sponsor: GlaxoSmithKline
Enrollment: 45
Locations: 1
Primary Endpoint: Area Under the Curve for Glycolysis (AUCgly(0-90)) of Test Zinc-IPMP and Non-SLS Negative Control
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

November 9, 2015

End Date

December 11, 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
•Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon oral examination.
•Plaque sample acidogenicity in the pH range 5.0 to 5.7 at Visit.

Exclusion Criteria

•Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
•Women who are breast-feeding.
•Currently taking antibiotics or have taken antibiotics within 2 weeks of plaque assessment (Visit 2). A participant with any medical history that may prevent them from participating in the study until study conclusion (such as diabetes).
•Any sign of grossly carious lesions (active), moderate or severe periodontal conditions, or severe tooth wear.
•Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
•Current smokers, or smokers who have quit within 6 months of screening, or participants currently using smokeless forms of tobacco, e.g. Gutkha, Pan containing tobacco, Pan Masala.
•Current active caries or periodontitis that may compromise, in the opinion of the investigator, study outcomes or the health of the subject.
•Restorations in a poor state of repair that may, in the opinion of the investigator, compromise study outcomes or the health of the participant.
•Partial dentures or orthodontic appliances that may, in the opinion of the investigator, compromise study outcomes or the health of the participant.
•Recent history (within the last year) of alcohol or other substance abuse.

Outcomes

Primary Outcomes

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)

AUCgly(0-90) of Test zinc-IPMP and non-SLS negative control was calculated using trapezoidal method.

Secondary Outcomes

AUCgly(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control(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(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(Baseline up to 90 min)