Clinical trial NCT05999175: Open-label Trial Evaluating Four Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste, and Mouthwash
Official title: Evaluation of the Tolerability, Safety of Use, and Efficacy of Cosmetic Products for the Oral Care. In Use Test Under Dentist Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Hygiene
Toothbrushing
Dental Plaque
Keywords: Gingival sensitivity
manual toothbrush
mouthwash
oral hygiene
oral microbiota stability
oral mucosa
plaque reduction
toothbrush
toothpaste
Lead sponsor: Biokosmes Srl
Sponsor class: INDUSTRY
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2023-08-21
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Gums sensitivity
timeFrame: 28 days
measure: Rate of gingival irritations
timeFrame: 28 days
measure: Rate of oral mucosa lesions
timeFrame: 28 days
measure: Dental plaque assessment
timeFrame: 1 day
measure: Teeth colour assessment
timeFrame: 28 days
Secondary outcomes:
measure: Self-assessment questionnaire
timeFrame: 28 days
measure: Oral microbiota analysis
timeFrame: 28 days
measure: Serious Adverse Events/Adverse Events
timeFrame: 14 days
Other outcomes:
Locations:
city: San Genesio ed Uniti
country: Italy
facility: Studio D. Cattaneo
state: Pavia
city: San Martino Siccomario
country: Italy
facility: Complife Italia Srl
state: Pavia
Study officials:
affiliation: San Genesio ed Uniti, Pavia (Italy)
name: Dario Cattaneo, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.