Open-label Trial Evaluating Four Oral Hygiene Regimens Using a Manual

Status Completed

Clinical Trial Summary

The purpose of this open-label, randomized controlled clinical trial, is to provide preliminary clinical data (efficacy on plaque and gingival sensitivity, and safety and tolerability of two types of toothpaste, a mouthwash, and a specifically custom-designed toothbrush used for 28 days), as well as descriptive data on the effects of the products on oral microbiota rebalancing and patient acceptability. Eighty-four participants with a history of poor oral hygiene are visited at baseline and after 28 days of administration of the tested products. The control group consisted of 12 participants who continued to use their oral care products without changing their normal routine. At baseline and at the end of treatment (final visit), the oral microbiome is also evaluated in a group of 12 subjects allocated randomly.

Clinical Trial Description

A complete line of cosmetic products (Tau-marin Protezione e Prevenzione) was launched on the Italian market in 2023. These products are based on an innovative formulation containing a prebiotic (Bioecolia®) and a paraprobiotic based on Lactobacillus plantarum (SymrebootTM OC). The products are the toothpastes "Dentifricio Menta Delicata" and "Dentifricio Menta" and the mouthwash "Collutorio Menta". The products should preferably be used with the "Spazzolino tau-marin" toothbrush, which, thanks to the silver ions placed on the bristles, handle and head of the toothbrush, can eliminate Staphylococcus aureus, methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa and Escherichia coli bacteria. Bioecolia® is an alpha-glucan oligosaccharide that is a preferred substrate for commensal bacteria and selectively stimulates their growth. SymrebootTM OC belongs to the class of paraprobiotics, i.e. non-viable microbial cells (either intact or disrupted) or crude cell extracts, which, when administered in adequate amounts, provide a health benefit to the user. SymrebootTM OC consists of heat treated Lactobacillus plantarum HEAL19. The combined action of prebiotic and paraprobiotic results in the restoration of the symbiosis. Stability and preclinical tests confirm the safety of these products for oral hygiene. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05999175
Study type	Interventional
Source	Biokosmes Srl
Contact
Status	Completed
Phase	N/A
Start date	May 17, 2022
Completion date	September 9, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Open-label Trial Evaluating Four Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste, and Mouthwash

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms