Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05999175
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2023-07-20
Brief Title:
Open-label Trial Evaluating Four Oral Hygiene Regimens Using a Manual Toothbrush Toothpaste and Mouthwash
Sponsor:
Biokosmes Srl
Organization:
Biokosmes Srl
Study Overview
Official Title:
Evaluation of the Tolerability Safety of Use and Efficacy of Cosmetic Products for the Oral Care In Use Test Under Dentist Control
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None