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

NCT05999175 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-05-22

No results posted yet for this study

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

Interventions

DEVICE

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.

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.

DEVICE

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

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

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    collaborator OTHER

  • Biokosmes Srl

    lead INDUSTRY

Principal Investigators

  • Dario Cattaneo, DDS · San Genesio ed Uniti, Pavia (Italy)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-17
Primary Completion
2022-07-26
Completion
2022-09-09

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05999175 on ClinicalTrials.gov