Efficacy of an U-shape Automatic Electric Toothbrush in Plaque Removal
Primary Purpose
Dental Plaque, Toothbrushing
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
U-shape Automatic Electric Toothbrush
Usual home toothbrushing procedure
Conventional Electric Toothbrush
Sponsored by
About this trial
This is an interventional treatment trial for Dental Plaque
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 30 years;
- no fixed orthodontic equipment;
- 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
Sites / Locations
- SOD Odontostomatologia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
No Intervention
Active Comparator
Arm Label
U-shape Automatic Electric Toothbrush
Usual home toothbrushing procedure
No toothbrushing
Conventional Electric Toothbrush
Arm Description
Outcomes
Primary Outcome Measures
Full mouth plaque score
Percentage of sites that presents with plaque on the total of the sites examined (6 sites per tooth).
Secondary Outcome Measures
Feeling of "clean mouth"
Visual analogue scale from 0 to 10 where 0 indicates no feeling of clean mouth and 10 maximum feeling of clean mouth
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04119583
Brief Title
Efficacy of an U-shape Automatic Electric Toothbrush in Plaque Removal
Official Title
Efficacy of an U-shape Automatic Electric Toothbrush in Plaque Removal: a Crossover Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
February 14, 2020 (Actual)
Study Completion Date
February 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Florence
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque, Toothbrushing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
U-shape Automatic Electric Toothbrush
Arm Type
Experimental
Arm Title
Usual home toothbrushing procedure
Arm Type
Active Comparator
Arm Title
No toothbrushing
Arm Type
No Intervention
Arm Title
Conventional Electric Toothbrush
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
U-shape Automatic Electric Toothbrush
Intervention Description
The U-shape Automatic Electric Toothbrush will be applied for 30-45 seconds on the teeth of both arches without the use of toothpaste.
Intervention Type
Other
Intervention Name(s)
Usual home toothbrushing procedure
Intervention Description
Usual home toothbrushing procedure either with manual or electric toothbrush without the use of toothpaste.
Intervention Type
Other
Intervention Name(s)
Conventional Electric Toothbrush
Intervention Description
The Conventional Electric Toothbrush will be applied for 2 minutes on the teeth of both arches without the use of toothpaste.
Primary Outcome Measure Information:
Title
Full mouth plaque score
Description
Percentage of sites that presents with plaque on the total of the sites examined (6 sites per tooth).
Time Frame
Difference between pre- and post-brushing (time frame 10-15 minutes)
Secondary Outcome Measure Information:
Title
Feeling of "clean mouth"
Description
Visual analogue scale from 0 to 10 where 0 indicates no feeling of clean mouth and 10 maximum feeling of clean mouth
Time Frame
Post-brushing (time frame 1-2 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 30 years;
no fixed orthodontic equipment;
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
Facility Information:
Facility Name
SOD Odontostomatologia
City
Firenze
ZIP/Postal Code
50127
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Efficacy of an U-shape Automatic Electric Toothbrush in Plaque Removal
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