Evaluation of the Antibacterial Effect of a Toothpaste Containing Zinc Lactate

Oral Bacterial Infection Clinical Trial

Official title: 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

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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).

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Related Conditions & MeSH terms

• Bacterial Infections
• Oral Bacterial Infection

• NCT number: NCT05628571
• Study type: Interventional
• Source: Hospital Israelita Albert Einstein
• Contact: Leticia M Bezinelli, PhD
• Phone: 55 11 91589350
• Email: lebezinelli@einstein.br
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 1, 2023
• Completion date: June 30, 2023