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

NCT05999175 | Completed DMC

• 1 other identifier: 0002847/21
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

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.

Conditions

Oral Hygiene; Toothbrushing; Dental Plaque

Keywords

Gingival sensitivity; manual toothbrush; mouthwash; oral hygiene; oral microbiota stability; oral mucosa; plaque reduction; toothbrush; toothpaste

Outcome Measures

Primary Outcomes (5)

• 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.

  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).

  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).

  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.

  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).

  28 days

Secondary Outcomes (3)

• Self-assessment questionnaire

  28 days

• Oral microbiota analysis

  28 days

• Serious Adverse Events/Adverse Events

  14 days

Study Arms (5)

Group 1 (20 subjects)

OTHER

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

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)

OTHER

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

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)

OTHER

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

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)

OTHER

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

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)

OTHER

continuing to use their routine oral hygiene products.

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. DEVICE

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

Group 1 (20 subjects); Group 2 (12 subjects); Group 3 (20 subjects)

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.

Group 4 (20 subjects)

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

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

Group 5 (12 subjects)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biokosmes Srl: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (2)

Studio D. Cattaneo

San Genesio ed Uniti, Pavia, 27010, Italy

Location

Complife Italia Srl

San Martino Siccomario, Pavia, 27028, Italy

Location

Related Publications (5)

• 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.

  PMID: 32102216 BACKGROUND

• 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.

  PMID: 37025387 BACKGROUND

• 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.

  PMID: 27857087 BACKGROUND

• 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.

  PMID: 33916013 BACKGROUND

• 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.

  PMID: 38905608 RESULT

Related Links

• Bioecolia® is the prebiotic included in the tested products.

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Dario Cattaneo, DDS

  San Genesio ed Uniti, Pavia (Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 21, 2023
• Study Start: May 17, 2022
• Primary Completion: July 26, 2022
• Study Completion: September 9, 2022
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

IT (2)