A Study to Investigate the Antimicrobial Activity of 2 Test Toothpastes

NCT ID: NCT02856880

Last Updated: 2017-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-09
• Study Completion Date: 2015-12-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Test zinc-IPMP toothpaste

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

Test zinc non- IPMP toothpaste

Intervention Type: OTHER

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

Positive control Toothpaste

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

Group Type: ACTIVE_COMPARATOR

Positive control

Intervention Type: OTHER

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

SLS Negative Control

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

Group Type: ACTIVE_COMPARATOR

SLS negative control

Intervention Type: OTHER

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

non-SLS negative control

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

Group Type: ACTIVE_COMPARATOR

non-SLS negative control

Intervention Type: OTHER

Negative control toothpaste containing 1426 ppm fluoride as sodium fluoride

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Positive control

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

Intervention Type: OTHER

SLS negative control

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

Intervention Type: OTHER

non-SLS negative control

Negative control toothpaste containing 1426 ppm fluoride as sodium fluoride

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

205051

Identifier Type: -

Identifier Source: org_study_id