Efficacy of an Automatic Toothbrush
1 other identifier
interventional
25
1 country
1
Brief Summary
The objective of this study is to compare the efficacy in terms of bacterial plaque removal, in a single use, of a new Y-shaped automatic electric toothbrush with nylon bristles, compared with the electric toothbrush of similar shape but with silicone bristles, with the manual toothbrush, and with a negative control (no brushing) in a group of volunteer students. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2022
CompletedFirst Posted
Study publicly available on registry
October 26, 2022
CompletedStudy Start
First participant enrolled
November 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2022
CompletedApril 18, 2023
April 1, 2023
1 month
October 21, 2022
April 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in full mouth plaque score
Difference in full mouth plaque score between before and after brushing
5 minutes
Secondary Outcomes (1)
Perception of "clean mouth"
5 minutes
Study Arms (5)
Automatic toothbrush with nylon bristles
EXPERIMENTALAutomatic toothbrush with silicone bristles
ACTIVE COMPARATORManual toothbrush used for 2 minutes
ACTIVE COMPARATORManual toothbrush used for 45 seconds
ACTIVE COMPARATORNo brushing
NO INTERVENTIONInterventions
The automatic toothbrush with nylon bristles will be used for 10 seconds per dental arch
The automatic toothbrush with silicone bristles will be used for 10 seconds
A conventional manual toothbrush will be used for 2 minutes
A conventional manual toothbrush will be used for 45 seconds
Eligibility Criteria
You may qualify if:
- Absence of fixed orthodontic appliances
- Presence of at least 20 teeth
- Full mouth plaque score greater than 40%
- Having provided signed and dated informed consent.
You may not qualify if:
- Subjects with manual inability to perform normal oral hygiene maneuvers
- Subjects allergic to silicone or nylon.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Dentistry, The University of Florence
Florence, 50127, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 21, 2022
First Posted
October 26, 2022
Study Start
November 7, 2022
Primary Completion
December 21, 2022
Study Completion
December 21, 2022
Last Updated
April 18, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share