Evaluation of the Antibacterial Effect of a Toothpaste Containing Zinc Lactate

Study Overview
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Brief Summary
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The aim of this study is to evaluate the antibacterial effect 12 hours after 4-week use of a toothpaste containing amine base, zinc lactate, and fluoride. For this, healthy people will be invited to use two different toothpaste: control - containing only fluoride; test - containing fluoride plus a combination with zinc. The primary outcome is the efficacy of the test toothpaste in the oral bacterial load reduction in samples of saliva and oral mucosa (obtained through scraping); the second outcome is effect of the test toothpaste in the expression of mucin in the oral mucosa.

Detailed Description
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Study Design This is a phase III, randomized, single center, parallel-group, double-blind clinical study to evaluate the antibacterial effect of a toothpaste containing an amine, zinc lactate, and fluoride base. Primary Objective The objective of this study is to evaluate the antibacterial effect 12 hours after using a toothpaste containing amine, zinc lactate and fluoride for 4 weeks. Secondary Objectives The secondary objective will be to evaluate the impact of a toothpaste containing amine, zinc lactate and fluoride in the quantification of mucin on the surface of the oral mucosa. Study Intervention Design: Parallel Product Assignment: Randomization Number of individuals: 130 Individuals by age group: 18 to 70 Number of test groups: 2 Treatment regimen: Brushing of the entire mouth with test toothpaste Blind Mode: Double-blind Number of exposures (uses): Twice a day, unattended Study duration: 6 weeks Washout period: Yes Duration of each exposure: 2 minutes of brushing Study Groups: 1) Test Group: Toothpaste containing amine base, zinc lactate and fluorine (1400 ppm F). C

Official Title
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Clinical Research Study to Evaluate the Antibacterial Effect 12 Hours After 4-week Use of a Toothpaste Containing Amine Base, Sodium Fluoride and Zinc Lactate

Conditions
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Oral Bacterial Infection

Intervention / Treatment
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* Combination Product: Zinc toothpaste
* Combination Product: Fluoride Toothpaste


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Fluoride toothpaste<br>Participants will brush their teeth with a commercially available Fluoride toothpaste (1450 ppm F) and a commercially available adult soft bristle toothbrush | Combination Product: Fluoride Toothpaste<br>* Participants will brush their teeth with a commercially available, soft-bristle adult toothbrush and toothpaste containing fluoride (1450 ppm F).<br>|
| Experimental: Zinc toothpaste<br>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 | Combination Product: Zinc toothpaste<br>* Participants will brush their teeth with a commercially available, soft-bristle adult toothbrush and toothpaste containing amine-based zinc lactate (0.1%) and fluoride (1400 ppm F).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of oral bacteria load | analysis of oral bacterial load (log10 colony-forming unit/mL) in saliva and oral mucosa biofilm samples, performed by microbial culture | Baseline (previously of the interventions) and after 4 weeks of the interventions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of mucin expression in oral mucosa samples | quantification of mucin expression produced by the mucin gene (pg/mL) present in samples of the jugal mucosa, performed by means of an ELISA immunoenzymatic test. | Baseline (previously of the interventions) and after 1, 2, 3 and 4 weeks of the interventions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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toothpastes, fluoride, antimicrobial effect, oral bacteria, mucin, zinc