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Oral HygieneNCT05999175

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

A study testing 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. and subjects of this group will use their routine oral hygiene products. in people with Oral Hygiene and Toothbrushing, run by Biokosmes Srl at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Oral Hygiene, Toothbrushing, Dental Plaque
What is being tested?
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. and subjects of this group will use their routine oral hygiene products.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
2 sitesItaly
Study dates
17 May 2022to 9 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • Studio D. Cattaneo

    San Genesio ed Uniti, Pavia, 27010

  • Complife Italia Srl

    San Martino Siccomario, Pavia, 27028

Other trials in Italy

About this study

Official title: Evaluation of the Tolerability, Safety of Use, and Efficacy of Cosmetic Products for the Oral Care. In Use Test Under Dentist Control

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.

Read the 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.

Being tested
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.
Keywords
Gingival sensitivity, manual toothbrush, mouthwash, oral hygiene, oral microbiota stability, oral mucosa, plaque reduction, toothbrush, toothpaste
Medical subject headings
Dental Plaque

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.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.

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

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

Study groups in NCT05999175
Study groupRoleWhat they receive
Group 1 (20 subjects)Otherusing the delicate mint toothpaste "Dentifricio gel tau-marin® Menta Delicata".
Receives: 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)Otherusing of the mint toothpaste "Dentifricio gel tau-marin® Menta".
Receives: 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)Otherusing the mint mouthwash "Collutorio tau-marin® Menta.
Receives: 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)Otherusing the delicate mint toothpaste "Dentifricio gel tau-marin® Menta Delicata", mint mouthwash "Collutorio tau-marin® Menta".
Receives: 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)Othercontinuing to use their routine oral hygiene products.
Receives: Device: subjects of this group will use their routine oral hygiene products.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 28 days

  2. 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).

    Measured: 28 days

  3. 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).

    Measured: 28 days

  4. 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.

    Measured: 1 day

  5. 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).

    Measured: 28 days

Secondary outcomes (3)

  1. Self-assessment questionnaire

    Subjects are asked to complete a self-report questionnaire on Timm (immediately after first use) and on days 14 and 28.

    Measured: 28 days

  2. 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)

    Measured: 28 days

  3. Serious Adverse Events/Adverse Events

    The number of participants with treatment-related adverse events will be assessed by CTCAE v6.0

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start17 May 2022
  3. Primary completion26 Jul 2022
  4. Study completion9 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05999175
Sponsor's protocol ID
0002847/21
Status last verified
May 2025
First submitted
20 Jul 2023
Last updated
22 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32102216

  • 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.

    PubMed 37025387

  • 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.

    PubMed 27857087

  • 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.

    PubMed 33916013

  • 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.

    PubMed 38905608

Questions about this trial

What is this clinical trial studying?

A study testing 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. and subjects of this group will use their routine oral hygiene products. in people with Oral Hygiene and Toothbrushing, run by Biokosmes Srl at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gums sensitivity (time frame: 28 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05999175, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.

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