Efficacy of an U-shape Automatic Electric Toothbrush in Plaque Removal
1 other identifier
interventional
22
1 country
1
Brief Summary
Over time, many different types of manual and electric toothbrushes have been produced. A systematic review has shown that some electric toothbrushes are more effective at removing bacterial plaque than manual toothbrushes. A new U-shaped electric toothbrush with silicone bristles has recently been produced that has a fully automatic and simultaneous action on both arches. However, its efficacy in removing bacterial plaque is not clear at the moment, as no randomized study has been published on this type of toothbrush. 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.
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 Jan 2020
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 3, 2019
CompletedFirst Posted
Study publicly available on registry
October 8, 2019
CompletedStudy Start
First participant enrolled
January 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2020
CompletedMarch 24, 2020
March 1, 2020
25 days
October 3, 2019
March 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Full mouth plaque score
Percentage of sites that presents with plaque on the total of the sites examined (6 sites per tooth).
Difference between pre- and post-brushing (time frame 10-15 minutes)
Secondary Outcomes (1)
Feeling of "clean mouth"
Post-brushing (time frame 1-2 minutes)
Study Arms (4)
U-shape Automatic Electric Toothbrush
EXPERIMENTALUsual home toothbrushing procedure
ACTIVE COMPARATORNo toothbrushing
NO INTERVENTIONConventional Electric Toothbrush
ACTIVE COMPARATORInterventions
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 either with manual or electric toothbrush without the use of toothpaste.
The Conventional Electric Toothbrush will be applied for 2 minutes on the teeth of both arches without the use of toothpaste.
Eligibility Criteria
You may qualify if:
- Age between 18 and 30 years;
- no fixed orthodontic equipment;
- presence of at least 20 teeth;
- Full mouth plaque score (FMPS) above 40%.
You may not qualify if:
- Subjects with manual disabilities to perform normal oral hygiene maneuvers;
- Subjects allergic to silicone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SOD Odontostomatologia
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
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor in Dentistry
Study Record Dates
First Submitted
October 3, 2019
First Posted
October 8, 2019
Study Start
January 20, 2020
Primary Completion
February 14, 2020
Study Completion
February 14, 2020
Last Updated
March 24, 2020
Record last verified: 2020-03