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
25 participants
INTERVENTIONAL
2022-11-07
2022-12-21
Brief Summary
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Primary endpoint: difference in "full mouth plaque score" between before and after brushing.
Secondary endpoint: sensation of "clean mouth" assessed on VAS scale from 0 to 10 where 0 indicates no sensation of clean mouth and 10 maximum sensation of clean mouth.
Single-center, randomized, controlled, superiority, cross-over, examiner-blinded study with 5 treatments (Y-shaped electric toothbrush with nylon bristles, similarly shaped electric toothbrush with silicone bristles, manual brushing for 45 seconds, manual brushing for 2 minutes, no brushing), carried out in a single session and spaced one week apart.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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Automatic toothbrush with nylon bristles
Automatic toothbrush with nylon bristle
The automatic toothbrush with nylon bristles will be used for 10 seconds per dental arch
Automatic toothbrush with silicone bristles
Automatic toothbrush with silicone bristle
The automatic toothbrush with silicone bristles will be used for 10 seconds
Manual toothbrush used for 2 minutes
Manual toothbrush used for 2 minutes
A conventional manual toothbrush will be used for 2 minutes
Manual toothbrush used for 45 seconds
Manual toothbrush used for 45 seconds
A conventional manual toothbrush will be used for 45 seconds
No brushing
No interventions assigned to this group
Interventions
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Automatic toothbrush with nylon bristle
The automatic toothbrush with nylon bristles will be used for 10 seconds per dental arch
Automatic toothbrush with silicone bristle
The automatic toothbrush with silicone bristles will be used for 10 seconds
Manual toothbrush used for 2 minutes
A conventional manual toothbrush will be used for 2 minutes
Manual toothbrush used for 45 seconds
A conventional manual toothbrush will be used for 45 seconds
Eligibility Criteria
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Inclusion Criteria
* Presence of at least 20 teeth
* Full mouth plaque score greater than 40%
* Having provided signed and dated informed consent.
Exclusion Criteria
* Subjects allergic to silicone or nylon.
18 Years
30 Years
ALL
Yes
Sponsors
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University of Florence
OTHER
Responsible Party
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Lorenzo Franchi
Professor
Locations
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School of Dentistry, The University of Florence
Florence, , Italy
Countries
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Other Identifiers
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IUFET2
Identifier Type: -
Identifier Source: org_study_id
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