Open-label Trial Evaluating Four Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste, and Mouthwash
Condition: Oral Hygiene; Toothbrushing; Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional

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.
    

Intervention name(s): 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.
Intervention type(s): Device; Device; Device
Intervention description(s): 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.
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study participants would be randomly allocated to one of the following groups: Group 1 (20 subjects) would use the delicate mint toothpaste "Dentifricio gel tau-marin® Menta Delicata"; Group 2 (12 subjects) mint toothpaste " Dentifricio gel tau-marin® Menta"; Group 3 (20 subjects) mint mouthwash "Collutorio tau-marin® Menta". Group 4 (20 subjects) would utilize delicate mint toothpaste "Dentifricio gel tau-marin® Menta Delicata" and mint mouthwash " Collutorio tau-marin® Menta". These products would be applied with tau-marin® scalar toothbrush 33 medium with antibacterial "Spazzolino tau-marin®" three times a day after the main meals for 28 days. Group 5 (12 subjects) would continue to use routine oral hygiene products for 28 days. Groups 1 to 3 would be provided with a standard toothbrush (without any claims of efficacy) to be used three times a day after the main meals for 28 days.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Gingival sensitivity; manual toothbrush; mouthwash; oral hygiene; oral microbiota stability; oral mucosa; plaque reduction; toothbrush; toothpaste