A Study to Investigate the Antimicrobial Activity of 2 Test Toothpastes

NCT02856880 | Completed Results

• 1 other identifier: 205051
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Dental Plaque

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• AUCgly(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control

  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

  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

  Baseline up to 90 min

Study Arms (5)

Test zinc-IPMP toothpaste

EXPERIMENTAL

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 zinc non- IPMP toothpaste

EXPERIMENTAL

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

Other: Test zinc non- IPMP toothpaste

Positive control Toothpaste

ACTIVE COMPARATOR

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

Other: Positive control

SLS Negative Control

ACTIVE COMPARATOR

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

Other: SLS negative control

non-SLS negative control

ACTIVE COMPARATOR

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

Other: non-SLS negative control

Interventions

Test zinc-IPMP toothpaste OTHER

Test toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426ppm fluoride as sodium fluoride.

Test zinc-IPMP toothpaste

Test zinc non- IPMP toothpaste OTHER

Test toothpaste containing 0.6% w/w zinc chloride, 0% w/w IPMP and 1426ppm fluoride as sodium fluoride.

Test zinc non- IPMP toothpaste

Positive control OTHER

Positive control toothpaste containing 0.454% w/w stannous fluoride (Fluoride Toothpaste (1100ppm Fluoride as stannous fluoride)).

Positive control Toothpaste

SLS negative control OTHER

Negative control toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150 ppm fluoride as sodium fluoride

SLS Negative Control

non-SLS negative control OTHER

Negative control toothpaste containing 1426 ppm fluoride as sodium fluoride

non-SLS negative control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Manchester, M16 9HQ, United Kingdom

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: August 5, 2016
• Study Start: November 9, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 11, 2015
• Last Updated: August 30, 2017
• Results First Posted: March 3, 2017

Record last verified: 2017-07

Locations

GB (1)