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Evaluation of the Antibacterial Effect of a Toothpaste Containing Zinc Lactate

Primary Purpose

Oral Bacterial Infection

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Zinc toothpaste
Fluoride Toothpaste
Sponsored by
Hospital Israelita Albert Einstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Bacterial Infection focused on measuring toothpastes, fluoride, antimicrobial effect, oral bacteria, mucin, zinc

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Fluoride toothpaste

    Zinc toothpaste

    Arm Description

    Participants will brush their teeth with a commercially available Fluoride toothpaste (1450 ppm F) and a commercially available adult soft bristle toothbrush

    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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    November 7, 2022
    Last Updated
    January 11, 2023
    Sponsor
    Hospital Israelita Albert Einstein
    Collaborators
    Colgate Palmolive, Associação Latinoamericana para Promoção de Saúde Bucal e Pesquisa Odontológica (LAOHA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05628571
    Brief Title
    Evaluation of the Antibacterial Effect of a Toothpaste Containing Zinc Lactate
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    April 30, 2023 (Anticipated)
    Study Completion Date
    June 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospital Israelita Albert Einstein
    Collaborators
    Colgate Palmolive, Associação Latinoamericana para Promoção de Saúde Bucal e Pesquisa Odontológica (LAOHA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Bacterial Infection
    Keywords
    toothpastes, fluoride, antimicrobial effect, oral bacteria, mucin, zinc

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Masking Description
    Randomization lists will be kept confidential by the Investigator, inside a locked cabinet. As patients are included by the Examiner at the first visit (T0), the Investigator will make the allocation. The Examiner and other team members, including the Laboratory Technician, will not know the group to which the patient belongs. Toothpastes will be covered with white paper to disguise the identity of the product. Participants will also not know which group they belong to and which investigational product they are using. To this end, the products will be distributed in a separate area of the exam room by the Assistant, without the other participants being present. The samples will also be labeled with the information of the participant's first and last name initials, the randomization code and the sample collection data (type, intraoral location and collection date). The Laboratory Technician will not know which group the sample belongs to.
    Allocation
    Randomized
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fluoride toothpaste
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will brush their teeth with a commercially available Fluoride toothpaste (1450 ppm F) and a commercially available adult soft bristle toothbrush
    Arm Title
    Zinc toothpaste
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Combination Product
    Intervention Name(s)
    Zinc toothpaste
    Intervention Description
    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).
    Intervention Type
    Combination Product
    Intervention Name(s)
    Fluoride Toothpaste
    Intervention Description
    Participants will brush their teeth with a commercially available, soft-bristle adult toothbrush and toothpaste containing fluoride (1450 ppm F).
    Primary Outcome Measure Information:
    Title
    Change of oral bacteria load
    Description
    analysis of oral bacterial load (log10 colony-forming unit/mL) in saliva and oral mucosa biofilm samples, performed by microbial culture
    Time Frame
    Baseline (previously of the interventions) and after 4 weeks of the interventions
    Secondary Outcome Measure Information:
    Title
    Change of mucin expression in oral mucosa samples
    Description
    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.
    Time Frame
    Baseline (previously of the interventions) and after 1, 2, 3 and 4 weeks of the interventions

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Leticia M Bezinelli, PhD
    Phone
    55 11 91589350
    Email
    lebezinelli@einstein.br
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fernanda de P Eduardo, PhD
    Phone
    5511999037553
    Email
    fpeduard@einstein.br

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing 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.
    Citations:
    PubMed Identifier
    2597059
    Citation
    Aguirre A, Mendoza B, Levine MJ, Hatton MN, Douglas WH. In vitro characterization of human salivary lubrication. Arch Oral Biol. 1989;34(8):675-7. doi: 10.1016/0003-9969(89)90024-1.
    Results Reference
    background
    PubMed Identifier
    32944154
    Citation
    Ben Lagha A, Yang Y, Trivedi HM, Masters JG, Grenier D. A Dual Zinc plus Arginine formulation attenuates the pathogenic properties of Porphyromonas gingivalis and protects gingival keratinocyte barrier function in an in vitro model. J Oral Microbiol. 2020 Aug 4;12(1):1798044. doi: 10.1080/20002297.2020.1798044. Erratum In: J Oral Microbiol. 2020 Sep 2;12(1):1813916.
    Results Reference
    background
    PubMed Identifier
    36171634
    Citation
    Carda-Dieguez M, Moazzez R, Mira A. Functional changes in the oral microbiome after use of fluoride and arginine containing dentifrices: a metagenomic and metatranscriptomic study. Microbiome. 2022 Sep 28;10(1):159. doi: 10.1186/s40168-022-01338-4.
    Results Reference
    background
    PubMed Identifier
    29301123
    Citation
    Creeth JE, Karwal R, Hara AT, Zero DT. A Randomized in situ Clinical Study of Fluoride Dentifrices on Enamel Remineralization and Resistance to Demineralization: Effects of Zinc. Caries Res. 2018;52(1-2):129-138. doi: 10.1159/000479823. Epub 2018 Jan 5.
    Results Reference
    background
    PubMed Identifier
    30620869
    Citation
    Delgado E, Garcia-Godoy F, Montero-Aguilar M, Mateo LR, Ryan M. A Clinical Investigation of a Dual Zinc plus Arginine Dentifrice in Reducing Established Dental Plaque and Gingivitis Over a Six-Month Period of Product Use. J Clin Dent. 2018 Sep;29(Spec No A):A33-40.
    Results Reference
    background
    PubMed Identifier
    22958385
    Citation
    Kindblom C, Davies JR, Herzberg MC, Svensater G, Wickstrom C. Salivary proteins promote proteolytic activity in Streptococcus mitis biovar 2 and Streptococcus mutans. Mol Oral Microbiol. 2012 Oct;27(5):362-72. doi: 10.1111/j.2041-1014.2012.00650.x. Epub 2012 May 25.
    Results Reference
    background
    PubMed Identifier
    30620866
    Citation
    Manus LM, Daep CA, Begum-Gafur R, Makwana E, Won B, Yang Y, Huang XY, Maloney V, Trivedi HM, Wu D, Masters JG. Enhanced In Vitro Zinc Bioavailability through Rational Design of a Dual Zinc plus Arginine Dentifrice. J Clin Dent. 2018 Sep;29(Spec No A):A10-19.
    Results Reference
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    Evaluation of the Antibacterial Effect of a Toothpaste Containing Zinc Lactate

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