A Study to Investigate the Antimicrobial Activity of 2 Test Toothpastes

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

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).

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.