Oral Bacterial InfectionPhase 3NCT05628571

Evaluation of the Antibacterial Effect of a Toothpaste Containing Zinc Lactate

A Phase 3 study testing Zinc toothpaste and Fluoride Toothpaste in people with Oral Bacterial Infection, run by Hospital Israelita Albert Einstein.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Oral Bacterial Infection
What is being tested?: Zinc toothpaste and Fluoride Toothpaste
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 130 participants
Where: No sites listed yet
Study dates: 1 Feb 2023to 30 Jun 2023
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 16Show fewer

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.

Trial locations and contacts

No sites are listed yet.

Leticia M Bezinelli, PhD contact

55 11 91589350

lebezinelli@einstein.br

Fernanda de P Eduardo, PhD contact

5511999037553

fpeduard@einstein.br

About this study

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

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.

Read the 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:

Test Group: Toothpaste containing amine base, zinc lactate and fluorine (1400 ppm F).

Conditions: Oral Bacterial Infection
Being tested: Zinc toothpaste, Fluoride Toothpaste
Keywords: toothpastes, fluoride, antimicrobial effect, oral bacteria, mucin, zinc
Medical subject headings: Medullary cystic kidney disease 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05628571
Study group	Role	What they receive
Fluoride toothpaste	Placebo comparator	Participants will brush their teeth with a commercially available Fluoride toothpaste (1450 ppm F) and a commercially available adult soft bristle toothbrush Receives: Combination Product: Fluoride Toothpaste
Zinc toothpaste	Experimental	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 Receives: Combination Product: Zinc toothpaste

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline (previously of the interventions) and after 4 weeks of the interventions

Secondary outcomes (1)

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.
Measured: Baseline (previously of the interventions) and after 1, 2, 3 and 4 weeks of the interventions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202330 Jun 2023

First posted28 Nov 2022
Study start1 Feb 2023 (estimated)
Primary completion30 Apr 2023 (estimated)
Study completion30 Jun 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Oral Bacterial InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 130 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05628571
Sponsor's protocol ID: CRO-2022-05-MC-MD-BZ-BS
Status last verified: Nov 2022
First submitted: 7 Nov 2022
Last updated: 12 Jan 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

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.
PubMed 2597059
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.
PubMed 32944154
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.
PubMed 36171634
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.
PubMed 29301123
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.
PubMed 30620869
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.
PubMed 22958385
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.
PubMed 30620866

Want to know more?

Leticia M Bezinelli, PhD

55 11 91589350

lebezinelli@einstein.br

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Oral Bacterial Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05628571
Acronym / sponsor ID: CRO-2022-05-MC-MD-BZ-BS
Conditions: Oral Bacterial Infection
Keywords: toothpastes, fluoride, antimicrobial effect, oral bacteria, mucin, zinc
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 130 participants (estimated)
Lead sponsor: Hospital Israelita Albert EinsteinUniversity, hospital or other
Collaborators: Colgate Palmolive, Associação Latinoamericana para Promoção de Saúde Bucal e Pesquisa Odontológica (LAOHA)
Study start: 1 Feb 2023 (estimated)
Primary completion: 30 Apr 2023 (estimated)
Study completion: 30 Jun 2023 (estimated)
First posted: 28 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study Groups:

Test Group: Toothpaste containing amine base, zinc lactate and fluorine (1400 ppm F).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Fluoride toothpaste	Placebo comparator	Combination Product: Fluoride ToothpasteParticipants will brush their teeth with a commercially available Fluoride toothpaste (1450 ppm F) and a commercially available adult soft bristle toothbrush
Zinc toothpaste	Experimental	Combination Product: Zinc toothpasteParticipants 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

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Zinc toothpasteParticipants 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	Zinc toothpaste
Fluoride ToothpasteParticipants will brush their teeth with a commercially available, soft-bristle adult toothbrush and toothpaste containing fluoride (1450 ppm F).	Combination product	Fluoride toothpaste

Primary outcome

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

1 secondary outcome

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
Background: PubMed 2597059Aguirre 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.
Background: PubMed 32944154Ben 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.
Background: PubMed 36171634Carda-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.
Background: PubMed 29301123Creeth 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.
Background: PubMed 30620869Delgado 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.
Background: PubMed 22958385Kindblom 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.
Background: PubMed 30620866Manus 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.
Individual participant dataSharing planned: No. 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.

Related trials for Oral Bacterial Infection

Not yet recruitingPhase 4
Oral Switch in Bloodstream Infections in Immunocompromised Children
Bloodstream Infection, Bloodstream Infection Due to Central Venous Catheter
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
Not yet recruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leticia M Bezinelli, PhD contact

55 11 91589350

lebezinelli@einstein.br

Fernanda de P Eduardo, PhD contact

5511999037553

fpeduard@einstein.br

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zinc toothpaste and Fluoride Toothpaste in people with Oral Bacterial Infection, run by Hospital Israelita Albert Einstein.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Leticia M Bezinelli, PhD (55 11 91589350, lebezinelli@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of oral bacteria load (time frame: Baseline (previously of the interventions) and after 4 weeks of the interventions). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05628571, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.