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

NCT ID: NCT05999175

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-17
• Study Completion Date: 2022-09-09

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, 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1 (20 subjects)

using the delicate mint toothpaste "Dentifricio gel tau-marin® Menta Delicata".

Group Type: OTHER

the toothpaste is used with a standard toothbrush without any claims 3 times a day after the main meals for 28 days.

Intervention Type: DEVICE

the toothpaste is used with a standard toothbrush without any claims 3 times a day after the main meals for 28 days.

Group 2 (12 subjects)

using of the mint toothpaste "Dentifricio gel tau-marin® Menta".

Group Type: OTHER

the toothpaste is used with a standard toothbrush without any claims 3 times a day after the main meals for 28 days.

Intervention Type: DEVICE

the toothpaste is used with a standard toothbrush without any claims 3 times a day after the main meals for 28 days.

Group 3 (20 subjects)

using the mint mouthwash "Collutorio tau-marin® Menta.

Group Type: OTHER

the toothpaste is used with a standard toothbrush without any claims 3 times a day after the main meals for 28 days.

Intervention Type: DEVICE

the toothpaste is used with a standard toothbrush without any claims 3 times a day after the main meals for 28 days.

Group 4 (20 subjects)

using the delicate mint toothpaste "Dentifricio gel tau-marin® Menta Delicata", mint mouthwash "Collutorio tau-marin® Menta".

Group Type: OTHER

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.

Intervention Type: 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.

Group 5 (12 subjects)

continuing to use their routine oral hygiene products.

Group Type: OTHER

subjects of this group will use their routine oral hygiene products.

Intervention Type: DEVICE

subjects of this group will use their routine oral hygiene products.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

subjects of this group will use their routine oral hygiene products.

subjects of this group will use their routine oral hygiene products.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Healthy Caucasian males and females aged ≥ 18 to ≤ 65 years included.
• Proper oral hygiene not performed verified with Simplified Oral Hygiene Index (OHI-S) (score ≥ 2) and a questionnaire on oral habit.
• Patients able to comply with the requirements for the study and freely willing to provide written informed consent to the collection of their data.
• Registered with Italian National Health Service (NHS).
• Ability to understand the language used in the investigation center and to comply with the study procedures.
• Unbanned pharmacological therapy stable for at least one month without any changes during the study.
• Commitment not to change the daily routine and lifestyle.

Exclusion Criteria

• Allergies or sensitivity to oral care products, cosmetic products, drugs, patch or medical devices.
• Any oral cavity condition inappropriate for participation.
• Gums bleeding due to pathologies/pharmacological treatment.
• Concomitant or during the last week antibiotic therapy.
• Smokers (≥5 cigarettes/day).
• Acute, chronic or progressive diseases/illness/conditions able to interfere with the outcome of the study or considered dangerous or incompatible with the study requirements.
• Pathological staining of teeth.
• Breast-feeding, pregnancy, or women of child-bearing age unwilling to take the necessary precautions to avoid pregnancy during the study.
• Planning to participate or participation in other clinical trials withing 30 days.
• Hospitalization/planned hospitalization in a health or social facility.
• Deprivation of freedom by administrative or legal decision or under guardianship
• Inability to be contacted in case of emergency.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Opera CRO, a TIGERMED Group Company

OTHER

Sponsor Role: collaborator

Biokosmes Srl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dario Cattaneo, DDS

Role: PRINCIPAL_INVESTIGATOR

San Genesio ed Uniti, Pavia (Italy)

Locations

Studio D. Cattaneo

San Genesio ed Uniti, Pavia, Italy

Complife Italia Srl

San Martino Siccomario, Pavia, Italy

Countries

Italy

References

Willis JR, Gabaldon T. The Human Oral Microbiome in Health and Disease: From Sequences to Ecosystems. Microorganisms. 2020 Feb 23;8(2):308. doi: 10.3390/microorganisms8020308.

Reference Type: BACKGROUND

PMID: 32102216 (View on PubMed)

Abdulkareem AA, Al-Taweel FB, Al-Sharqi AJB, Gul SS, Sha A, Chapple ILC. Current concepts in the pathogenesis of periodontitis: from symbiosis to dysbiosis. J Oral Microbiol. 2023 Apr 2;15(1):2197779. doi: 10.1080/20002297.2023.2197779. eCollection 2023.

Reference Type: BACKGROUND

PMID: 37025387 (View on PubMed)

Kilian M, Chapple IL, Hannig M, Marsh PD, Meuric V, Pedersen AM, Tonetti MS, Wade WG, Zaura E. The oral microbiome - an update for oral healthcare professionals. Br Dent J. 2016 Nov 18;221(10):657-666. doi: 10.1038/sj.bdj.2016.865.

Reference Type: BACKGROUND

PMID: 27857087 (View on PubMed)

Rajendiran M, Trivedi HM, Chen D, Gajendrareddy P, Chen L. Recent Development of Active Ingredients in Mouthwashes and Toothpastes for Periodontal Diseases. Molecules. 2021 Apr 1;26(7):2001. doi: 10.3390/molecules26072001.

Reference Type: BACKGROUND

PMID: 33916013 (View on PubMed)

Rosu S, Benatti P, Bianco S, Barattini DF, Nobile V, Mellai M, Cattaneo D. Pilot, open-label, randomized controlled clinical trial evaluating 4 oral hygiene regimens using a manual toothbrush, toothpaste, and mouthwash. Gen Dent. 2024 Jul-Aug;72(4):62-71.

Reference Type: RESULT

PMID: 38905608 (View on PubMed)

Related Links

https://www.solabia.com/cosmetics/product/bioecolia/

Bioecolia® is the prebiotic included in the tested products.

Other Identifiers

0002847/21

Identifier Type: -

Identifier Source: org_study_id