Efficacy of an U-shape Automatic Electric Toothbrush in Plaque Removal
NCT ID: NCT04119583
Last Updated: 2020-03-24
Study Results
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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COMPLETED
NA
22 participants
INTERVENTIONAL
2020-01-20
2020-02-14
Brief Summary
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The aim of this study is to compare the efficacy in terms of bacterial plaque removal in a single use of a new automatic U-shaped electric toothbrush, compared with the usual home toothbrushing procedure, a conventional electric toothbrush, and negative control (no toothbrushing) in a group of volunteer students of the School of Dentistry of the University of Florence, Italy.
Primary endpoint will be the difference in "full mouth plaque score" between before and after brushing. Secondary endpoints will be feeling of "clean mouth" evaluated on a VAS (Visual Analogue Scale) scale from 0 to 10 where 0 indicates no feeling of clean mouth and 10 maximum feeling of clean mouth.
This study will be a monocentric, randomized, controlled, superiority, cross-over study, with blind examiner and 4 therapies (U-shaped electric toothbrush, usual home toothbrushing procedure, conventional electric toothbrush, no toothbrushing), carried out in a single session with an interval of one week between the 4 therapies.
Study population will be students of the School of Dentistry who are healthy volunteers. Number of patients to be enrolled: 22. Inclusion criteria: age between 18 and 30 years; no fixed orthodontic appliance; presence of at least 20 teeth; Full mouth plaque score (FMPS) above 40%.
Exclusion criteria: subjects with manual disabilities to perform normal oral hygiene maneuvers; subjects allergic to silicone.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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U-shape Automatic Electric Toothbrush
U-shape Automatic Electric Toothbrush
The U-shape Automatic Electric Toothbrush will be applied for 30-45 seconds on the teeth of both arches without the use of toothpaste.
Usual home toothbrushing procedure
Usual home toothbrushing procedure
Usual home toothbrushing procedure either with manual or electric toothbrush without the use of toothpaste.
No toothbrushing
No interventions assigned to this group
Conventional Electric Toothbrush
Conventional Electric Toothbrush
The Conventional Electric Toothbrush will be applied for 2 minutes on the teeth of both arches without the use of toothpaste.
Interventions
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U-shape Automatic Electric Toothbrush
The U-shape Automatic Electric Toothbrush will be applied for 30-45 seconds on the teeth of both arches without the use of toothpaste.
Usual home toothbrushing procedure
Usual home toothbrushing procedure either with manual or electric toothbrush without the use of toothpaste.
Conventional Electric Toothbrush
The Conventional Electric Toothbrush will be applied for 2 minutes on the teeth of both arches without the use of toothpaste.
Eligibility Criteria
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Inclusion Criteria
* no fixed orthodontic equipment;
* presence of at least 20 teeth;
* Full mouth plaque score (FMPS) above 40%.
Exclusion Criteria
* Subjects allergic to silicone
18 Years
30 Years
ALL
Yes
Sponsors
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University of Florence
OTHER
Responsible Party
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Lorenzo Franchi
Associate Professor in Dentistry
Locations
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SOD Odontostomatologia
Florence, , Italy
Countries
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Other Identifiers
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IUFET1
Identifier Type: -
Identifier Source: org_study_id
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