Evaluation of the Antibacterial Effect of a Toothpaste Containing Zinc Lactate
Oral Bacterial Infection
About this trial
This is an interventional prevention trial for Oral Bacterial Infection focused on measuring toothpastes, fluoride, antimicrobial effect, oral bacteria, mucin, zinc
Eligibility Criteria
Inclusion Criteria: Male and female subjects, ages 18-70, inclusive; Subjects are available during study duration; Subject is in good general health; A minimum of 15 natural teeth with facial and lingual scorable surfaces, excluding third molars. A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subjects with baseline whole mouth scores of dental plaque of 1.5 or more and gingivitis index of 1.0 or more. Exclusion Criteria: Participation in any other clinical study or test panel including clinical studies with oral hygiene formulations within the one month prior to entry into the study. History of dental prophylaxis or treatments in the past month or during study duration. History of medical treatments (e.g: antibiotic, anti-inflammatory, anticoagulant, etc.) during the month preceding study enrollment. Subjects scheduled for any medical procedure during the course of the study. Difficulty complying with study procedures and examinations such as excessive gagging during oral assessment etc. History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergies to personal care/consumer products or their ingredients. History of diabetes, hepatic, renal disease, inflammatory conditions or transmittable diseases, e.g. heart disease or AIDS. History of rheumatic fever or medical conditions that require prophylactic antibiotics coverage prior to dental procedures. Presence of oral lesions. History of active or severe periodontal disease (PD > 4) and loose teeth. Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations). Fixed or removable orthodontic appliances or removable partial dentures. Current smokers and subjects with a history of alcohol or drug abuse. Use of phenolic flavored products, such as mint flavored candies and chewing gum, during the study period. Unable to refrain from oral hygiene for twelve (12) hours prior to scheduled visits. Positive Coronavirus Disease 2019 test 48 hours prior to the screening visit.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Fluoride toothpaste
Zinc toothpaste
Participants will brush their teeth with a commercially available Fluoride toothpaste (1450 ppm F) and a commercially available adult soft bristle toothbrush
Participants will brush their teeth with a toothpaste containing amine base, zinc lactate and fluoride (1400 ppm F) and a commercially available adult soft bristle toothbrush