A Study to Investigate the Antimicrobial Activity of 2 Test Toothpastes

Overview

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).

Full Title of Study: “A Study to Investigate the Antimicrobial Activity of Two Test Toothpastes in a Plaque Glycolysis and Regrowth Model”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 1, 2015

Interventions

  • 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.
  • 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.
  • Other: Positive control
    • Positive control toothpaste containing 0.454% w/w stannous fluoride (Fluoride Toothpaste (1100ppm Fluoride as stannous fluoride)).
  • Other: SLS negative control
    • Negative control toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150 ppm fluoride as sodium fluoride
  • Other: non-SLS negative control
    • Negative control toothpaste containing 1426 ppm fluoride as sodium fluoride

Arms, Groups and Cohorts

  • 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
  • Experimental: Test zinc non- IPMP toothpaste
    • Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water
  • Active Comparator: Positive control Toothpaste
    • Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water
  • Active Comparator: SLS Negative Control
    • Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water
  • Active Comparator: non-SLS negative control
    • Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

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