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Evaluation of the Antibacterial Effect of a Toothpaste Containing Zinc Lactate

NCT05628571 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2023-01-12

No results posted yet for this study

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.

Conditions

  • Oral Bacterial Infection

Interventions

COMBINATION_PRODUCT

Zinc toothpaste

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).

COMBINATION_PRODUCT

Fluoride Toothpaste

Participants will brush their teeth with a commercially available, soft-bristle adult toothbrush and toothpaste containing fluoride (1450 ppm F).

Sponsors & Collaborators

  • Colgate Palmolive

    collaborator INDUSTRY

  • Associação Latinoamericana para Promoção de Saúde Bucal e Pesquisa Odontológica (LAOHA)

    collaborator UNKNOWN

  • Hospital Israelita Albert Einstein

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2023-04-30
Completion
2023-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05628571 on ClinicalTrials.gov