Evaluation of the Antibacterial Effect of a Toothpaste Containing Zinc Lactate

NCT05628571 | Unknown Phase 3 DMC

• 1 other identifier: CRO-2022-05-MC-MD-BZ-BS
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oral Bacterial Infection

Keywords

toothpastes; fluoride; antimicrobial effect; oral bacteria; mucin; zinc

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (1)

• Change of mucin expression in oral mucosa samples

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

Study Arms (2)

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

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

Combination Product: Zinc toothpaste

Interventions

Zinc toothpaste COMBINATION_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).

Zinc toothpaste

Fluoride Toothpaste COMBINATION_PRODUCT

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

Fluoride toothpaste

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Colgate Palmolive: collaborator
• Associação Latinoamericana para Promoção de Saúde Bucal e Pesquisa Odontológica (LAOHA): collaborator

Related Publications (7)

• 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.

  PMID: 2597059 BACKGROUND

• 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.

  PMID: 32944154 BACKGROUND

• 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.

  PMID: 36171634 BACKGROUND

• 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.

  PMID: 29301123 BACKGROUND

• 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.

  PMID: 30620869 BACKGROUND

• 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.

  PMID: 22958385 BACKGROUND

• 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.

  PMID: 30620866 BACKGROUND

MeSH Terms

Conditions

Medullary cystic kidney disease 1

Interventions

green tea bioflavonoid, zinc ascorbate-containing toothpaste

Central Study Contacts

Leticia M Bezinelli, PhD

CONTACT

55 11 91589350; lebezinelli@einstein.br

Fernanda de P Eduardo, PhD

CONTACT

5511999037553; fpeduard@einstein.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 28, 2022
• Study Start: February 1, 2023
• Primary Completion: April 30, 2023
• Study Completion: June 30, 2023
• Last Updated: January 12, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share