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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
84
the toothpaste is used with a standard toothbrush without any claims 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.
subjects of this group will use their routine oral hygiene products.
Studio D. Cattaneo
San Genesio ed Uniti, Pavia, Italy
Complife Italia Srl
San Martino Siccomario, Pavia, Italy
Gums sensitivity
Change from baseline to day 14 and 28 days assessed by the Investigator during the dentist examination using a 10 cm visual analogue scale (VAS) where 0 is absence of sensitivity and 10 indicates the maximum of sensitivity.
Time frame: 28 days
Rate of gingival irritations
Change from baseline to 14 and 28 days assessed by the Investigator during the dentist examination as follows: (Yes presence of gingival irritation; No = absence of gingival irritation).
Time frame: 28 days
Rate of oral mucosa lesions
Change from baseline to 14 and 28 days assessed by the Investigator during the dentist examination as follows: (Yes presence of oral mucosa lesion; No = absence of oral mucosa lesion).
Time frame: 28 days
Dental plaque assessment
Change from T0 (at the baseline at visit, performed three hours after the last teeth brushing) to Timm (evaluation done immediately after the first product use). The evaluation is carried out by means of an erythrosine-based disclosing tablet, which allows to quantify the presence of plaque on the teeth. First, the dentist gives the tablet to the subjects, who are asked to chew it thoroughly in their mouths. Then, the subjects are asked to rub the chewed particles of the tablets on their teeth with their tongue and swish the accumulated saliva in their mouth for about 60 seconds before rinsing with water. The releasing tablet stains the plaque on the teeth.
Time frame: 1 day
Teeth colour assessment
Change from baseline to 14 and 28 days as assessed by the investigator during the dentist's examination comparing the subjects' teeth with those shown on the VITAPAN® Score. The scoring system consists of a series of 16 "artificial teeth" in 16 different colors, each of which is associated with an alphanumeric code representing the entire chromatic space of natural teeth. It classifies tooth color into 4 families of shades as follows: reddish-brownish (A1, A2, A3, A3.5, A4), reddish-yellowish (B1, B2, B3, B4), grayish (C1, C2, C3, C4) and reddish-grey (D2, D3, D4).
Time frame: 28 days
Self-assessment questionnaire
Subjects are asked to complete a self-report questionnaire on Timm (immediately after first use) and on days 14 and 28.
Time frame: 28 days
Oral microbiota analysis
It evaluates the change from baseline to 28 days. Oral microbiota is obtained by brushing a defined area of the mouth. Swabs are collected and stored at room temperature. Microbiome analysis is based on metagenomic analysis of the 16S rRNA gene. The second step in the analysis pipeline is to isolate the bacterial DNA from other components of the sample. Through a series of cell lysis and extraction steps, the purified bacterial material is obtained. The bacterial material is then amplified by PCR, first to increase the amount of DNA, and second to label the genetic material - which will later allow identification of each sample during the sequencing step. The concentrations of the samples are equalized prior to pooling to create the sequencing mix. This solution is then loaded into a cartridge and analyzed by a sequencer. The biodiversity index (Shannon index) and statistics are calculated using a dedicated software (Microbiome analyst)
Time frame: 28 days
Serious Adverse Events/Adverse Events
The number of participants with treatment-related adverse events will be assessed by CTCAE v6.0
Time frame: 14 days
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