Electric Toothbrush Efficacy in Preventing Dental Plaque Development

NCT ID: NCT06358482

Last Updated: 2024-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-30

Study Completion Date

2024-04-29

Brief Summary

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The present study will be the first to compared dental plaque quantitation between an oscillating-rotating electric toothbrush and a manual toothbrush with a new QLF technology.

Detailed Description

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This is a randomized controlled trial of 12-weeks duration designed to assess whether a new commercially available oscillating-rotating electric toothbrush can objectively improve dental plaque parameters obtained via light induced fluorescence (QLF) technology. The study will be conducted in a dental clinic in Italy

Conditions

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Dental Plaque Calculus, Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A Digital

oscillating-rotating electric toothbrush group

Group Type EXPERIMENTAL

oscillating toothbrush

Intervention Type BEHAVIORAL

oscillating toothbrush

B Manual

manual toothbrush group

Group Type ACTIVE_COMPARATOR

standard manual toothbrush

Intervention Type BEHAVIORAL

standard manual toothbrush

Interventions

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oscillating toothbrush

oscillating toothbrush

Intervention Type BEHAVIORAL

standard manual toothbrush

standard manual toothbrush

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* healthy adult (aged 18-50 years)
* non-smokers
* without clinical signs of periodontitis with at least 10 natural anterior teeth in total (cuspid to cuspid and lower and upper jaw).

Exclusion Criteria

* significant oral soft tissue pathology or any type of gingival overgrowth other than plaque-induced gingivitis,
* with fixed and removable orthodontic appliances or removable dentures,
* with any other medical condition that, in the opinion of the principal investigator, would jeopardize the participant's safety or diminish the validity of study results
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Riccardo Polosa

OTHER

Sponsor Role lead

Responsible Party

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Riccardo Polosa

Full Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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ADDENDO

Catania, , Italy

Site Status

Countries

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Italy

Other Identifiers

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ORAL1

Identifier Type: -

Identifier Source: org_study_id

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