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

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

130

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Hospital Israelita Albert Einstein

Collaborators

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)

February 1, 2023

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 24, 2022

First Posted (Actual)

November 28, 2022

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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