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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
University of Florence
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Plaque

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
October 3, 2019
Last Updated
March 23, 2020
Sponsor
University of Florence
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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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