Evaluation of the Antibacterial Effect of a Toothpaste Containing Zinc Lactate

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.

Timeline

Start

2023-02-01

Primary completion

2023-04-30

Completion

2023-06-30

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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Indications