A Study to Investigate the Antimicrobial Activity of 2 Test Toothpastes

Dental Plaque Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856880
• Other study ID #: 205051
• Status: Completed
• Phase: N/A
• First received: June 6, 2016
• Last updated: August 2, 2016
• Start date: October 2015
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dental Plaque

Intervention

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.
• Test zinc non- IPMP toothpaste
Test toothpaste containing 0.6% w/w zinc chloride, 0% w/w IPMP and 1426ppm fluoride as sodium fluoride.
• Positive control
Positive control toothpaste containing 0.454% w/w stannous fluoride (Fluoride Toothpaste (1100ppm Fluoride as stannous fluoride)).
• SLS negative control
Negative control toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150 ppm fluoride as sodium fluoride
• non-SLS negative control
Negative control toothpaste containing 1426 ppm fluoride as sodium fluoride

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No