A Study to Investigate the Antimicrobial Activity of 2 Test Toothpastes

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

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).

Study Overview

• Status: Completed
• Conditions: Dental Plaque
• Intervention / Treatment: Other: Test zinc-IPMP toothpaste; Other: Test zinc non- IPMP toothpaste; Other: Positive control; Other: SLS negative control; Other: non-SLS negative control

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M16 9HQ
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test zinc-IPMP toothpaste; Rinse with preprepared slurry of toothpaste in 10 milliliter (mL) water for 60 seconds(s) followed by rinse with 10mL water	Other: Test zinc-IPMP toothpaste; Test toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426ppm fluoride as sodium fluoride.
Experimental: Test zinc non- IPMP toothpaste; Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water	Other: Test zinc non- IPMP toothpaste; Test toothpaste containing 0.6% w/w zinc chloride, 0% w/w IPMP and 1426ppm fluoride as sodium fluoride.
Active Comparator: Positive control Toothpaste; Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water	Other: Positive control; Positive control toothpaste containing 0.454% w/w stannous fluoride (Fluoride Toothpaste (1100ppm Fluoride as stannous fluoride)).
Active Comparator: SLS Negative Control; Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water	Other: SLS negative control; Negative control toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150 ppm fluoride as sodium fluoride
Active Comparator: non-SLS negative control; Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water	Other: non-SLS negative control; Negative control toothpaste containing 1426 ppm fluoride as sodium fluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve for Glycolysis (AUCgly(0-90)) of Test Zinc-IPMP and Non-SLS Negative Control	AUCgly(0-90) of Test zinc-IPMP and non-SLS negative control was calculated using trapezoidal method.	Baseline up to 90 minutes (min)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCgly(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control	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.	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	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.	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	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.	Baseline up to 90 min

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 11, 2015

Study Registration Dates

• First Submitted: June 6, 2016
• First Submitted That Met QC Criteria: August 2, 2016
• First Posted (Estimate): August 5, 2016

Study Record Updates

• Last Update Posted (Actual): August 30, 2017
• Last Update Submitted That Met QC Criteria: July 31, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque; Physiological Effects of Drugs; Trace Elements; Micronutrients; Zinc
• Other Study ID Numbers: 205051