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A Study to Investigate the Antimicrobial Activity of 2 Test Toothpastes

Primary Purpose

Dental Plaque

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Test zinc-IPMP toothpaste
Test zinc non- IPMP toothpaste
Positive control
SLS negative control
non-SLS negative control
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dental Plaque

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Test zinc-IPMP toothpaste

Test zinc non- IPMP toothpaste

Positive control Toothpaste

SLS Negative Control

non-SLS negative control

Arm Description

Rinse with preprepared slurry of toothpaste in 10 milliliter (mL) water for 60 seconds(s) followed by rinse with 10mL water

Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water

Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water

Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water

Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 6, 2016
Last Updated
July 31, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT02856880
Brief Title
A Study to Investigate the Antimicrobial Activity of 2 Test Toothpastes
Official Title
A Study to Investigate the Antimicrobial Activity of Two Test Toothpastes in a Plaque Glycolysis and Regrowth Model
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 9, 2015 (Actual)
Primary Completion Date
December 1, 2015 (Actual)
Study Completion Date
December 11, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test zinc-IPMP toothpaste
Arm Type
Experimental
Arm Description
Rinse with preprepared slurry of toothpaste in 10 milliliter (mL) water for 60 seconds(s) followed by rinse with 10mL water
Arm Title
Test zinc non- IPMP toothpaste
Arm Type
Experimental
Arm Description
Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water
Arm Title
Positive control Toothpaste
Arm Type
Active Comparator
Arm Description
Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water
Arm Title
SLS Negative Control
Arm Type
Active Comparator
Arm Description
Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water
Arm Title
non-SLS negative control
Arm Type
Active Comparator
Arm Description
Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water
Intervention Type
Other
Intervention Name(s)
Test zinc-IPMP toothpaste
Intervention Description
Test toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426ppm fluoride as sodium fluoride.
Intervention Type
Other
Intervention Name(s)
Test zinc non- IPMP toothpaste
Intervention Description
Test toothpaste containing 0.6% w/w zinc chloride, 0% w/w IPMP and 1426ppm fluoride as sodium fluoride.
Intervention Type
Other
Intervention Name(s)
Positive control
Intervention Description
Positive control toothpaste containing 0.454% w/w stannous fluoride (Fluoride Toothpaste (1100ppm Fluoride as stannous fluoride)).
Intervention Type
Other
Intervention Name(s)
SLS negative control
Intervention Description
Negative control toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150 ppm fluoride as sodium fluoride
Intervention Type
Other
Intervention Name(s)
non-SLS negative control
Intervention Description
Negative control toothpaste containing 1426 ppm fluoride as sodium fluoride
Primary Outcome Measure Information:
Title
Area Under the Curve for Glycolysis (AUCgly(0-90)) of Test Zinc-IPMP and Non-SLS Negative Control
Description
AUCgly(0-90) of Test zinc-IPMP and non-SLS negative control was calculated using trapezoidal method.
Time Frame
Baseline up to 90 minutes (min)
Secondary Outcome Measure Information:
Title
AUCgly(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control
Description
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.
Time Frame
Baseline up to 90 min
Title
AUCregrowth(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control
Description
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.
Time Frame
Baseline up to 90 min
Title
AUClive:Dead(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control
Description
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.
Time Frame
Baseline up to 90 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Manchester
ZIP/Postal Code
M16 9HQ
Country
United Kingdom

12. IPD Sharing Statement

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