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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

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

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

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

NCT ID

NCT02856880

First Posted

June 6, 2016

Last Updated

July 31, 2017

Sponsor

GlaxoSmithKline

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

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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A Study to Investigate the Antimicrobial Activity of 2 Test Toothpastes

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