NCT05999175

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

Evaluation of the Tolerability, Safety of Use, and Efficacy of Cosmetic Products for the Oral Care. In Use Test Under Dentist Control

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Biokosmes Srl · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Oral Hygiene
• Toothbrushing
• Dental Plaque

Interventions

Type	Name	Description
DEVICE	the toothpaste is used with a standard toothbrush without any claims 3 times a day after the main meals for 28 days.	the toothpaste is used with a standard toothbrush without any claims 3 times a day after the main meals for 28 days.
DEVICE	the mint toothpaste and mouthwash are used with the scalar toothbrush 33 medium with antibacterial " Spazzolino tau-marin®" 3 times a day after the main meals for 28 days.	the mint toothpaste and mouthwash are used with the scalar toothbrush 33 medium with antibacterial " Spazzolino tau-marin®" 3 times a day after the main meals for 28 days.
DEVICE	subjects of this group will use their routine oral hygiene products.	subjects of this group will use their routine oral hygiene products.

Timeline

• Start date: 2022-05-17
• Primary completion: 2022-07-26
• Completion: 2022-09-09
• First posted: 2023-08-21
• Last updated: 2025-05-22

Locations

2 sites across 1 country: Italy