Evaluation of the Antibacterial Effect of a Toothpaste Containing Zinc Lactate

January 11, 2023 updated by: Hospital Israelita Albert Einstein

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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).

C

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female subjects, ages 18-70, inclusive;
  2. Subjects are available during study duration;
  3. Subject is in good general health;
  4. A minimum of 15 natural teeth with facial and lingual scorable surfaces, excluding third molars.
  5. A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them.
  6. Subjects with baseline whole mouth scores of dental plaque of 1.5 or more and gingivitis index of 1.0 or more.

Exclusion Criteria:

  1. 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.
  2. History of dental prophylaxis or treatments in the past month or during study duration.
  3. History of medical treatments (e.g: antibiotic, anti-inflammatory, anticoagulant, etc.) during the month preceding study enrollment.
  4. Subjects scheduled for any medical procedure during the course of the study.
  5. Difficulty complying with study procedures and examinations such as excessive gagging during oral assessment etc.
  6. 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.
  7. History of diabetes, hepatic, renal disease, inflammatory conditions or transmittable diseases, e.g. heart disease or AIDS.
  8. History of rheumatic fever or medical conditions that require prophylactic antibiotics coverage prior to dental procedures.
  9. Presence of oral lesions.
  10. History of active or severe periodontal disease (PD > 4) and loose teeth.
  11. Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations).
  12. Fixed or removable orthodontic appliances or removable partial dentures.
  13. Current smokers and subjects with a history of alcohol or drug abuse.
  14. Use of phenolic flavored products, such as mint flavored candies and chewing gum, during the study period.
  15. Unable to refrain from oral hygiene for twelve (12) hours prior to scheduled visits.
  16. Positive Coronavirus Disease 2019 test 48 hours prior to the screening visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Fluoride toothpaste
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
Participants will brush their teeth with a commercially available, soft-bristle adult toothbrush and toothpaste containing fluoride (1450 ppm F).
Experimental: Zinc toothpaste
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
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of oral bacteria load
Time Frame: Baseline (previously of the interventions) and after 4 weeks of the interventions
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of mucin expression in oral mucosa samples
Time Frame: Baseline (previously of the interventions) and after 1, 2, 3 and 4 weeks of the interventions
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Israelita Albert Einstein

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Colgate Palmolive
Associação Latinoamericana para Promoção de Saúde Bucal e Pesquisa Odontológica (LAOHA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRO-2022-05-MC-MD-BZ-BS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

All study data will be recorded on forms provided by the sponsor. Only the Investigator, Examiner and Assistant may make entries on the forms. Source data will be retained by the study site. Record security will include keeping written forms in locked and/or sealed file cabinets and/or labeled storage boxes located in a locked room. Access will be denied to all persons except the Principal Investigator and his designees.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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