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Efficacy of an Automatic Toothbrush

Primary Purpose

Dental Plaque

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Automatic toothbrush with nylon bristle
Automatic toothbrush with silicone bristle
Manual toothbrush used for 2 minutes
Manual toothbrush used for 45 seconds
Sponsored by
University of Florence
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dental Plaque

Eligibility Criteria

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Subjects with manual inability to perform normal oral hygiene maneuvers
  • Subjects allergic to silicone or nylon.

Sites / Locations

  • School of Dentistry, The University of Florence

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Automatic toothbrush with nylon bristles

Automatic toothbrush with silicone bristles

Manual toothbrush used for 2 minutes

Manual toothbrush used for 45 seconds

No brushing

Arm Description

Outcomes

Primary Outcome Measures

Change in full mouth plaque score
Difference in full mouth plaque score between before and after brushing

Secondary Outcome Measures

Perception of "clean mouth"
Sensation of "clean mouth" assessed on a visual analogue scale from 0 to 10 where 0 indicates no sensation of clean mouth and 10 maximum sensation of clean mouth

Full Information

First Posted
October 21, 2022
Last Updated
April 14, 2023
Sponsor
University of Florence
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1. Study Identification

Unique Protocol Identification Number
NCT05594134
Brief Title
Efficacy of an Automatic Toothbrush
Official Title
Efficacy of an Automatic Toothbrush With Nylon Bristles in Removing Dental Plaque: a Randomized Cross-over Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
December 21, 2022 (Actual)
Study Completion Date
December 21, 2022 (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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Automatic toothbrush with nylon bristles
Arm Type
Experimental
Arm Title
Automatic toothbrush with silicone bristles
Arm Type
Active Comparator
Arm Title
Manual toothbrush used for 2 minutes
Arm Type
Active Comparator
Arm Title
Manual toothbrush used for 45 seconds
Arm Type
Active Comparator
Arm Title
No brushing
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Automatic toothbrush with nylon bristle
Intervention Description
The automatic toothbrush with nylon bristles will be used for 10 seconds per dental arch
Intervention Type
Other
Intervention Name(s)
Automatic toothbrush with silicone bristle
Intervention Description
The automatic toothbrush with silicone bristles will be used for 10 seconds
Intervention Type
Other
Intervention Name(s)
Manual toothbrush used for 2 minutes
Intervention Description
A conventional manual toothbrush will be used for 2 minutes
Intervention Type
Other
Intervention Name(s)
Manual toothbrush used for 45 seconds
Intervention Description
A conventional manual toothbrush will be used for 45 seconds
Primary Outcome Measure Information:
Title
Change in full mouth plaque score
Description
Difference in full mouth plaque score between before and after brushing
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Perception of "clean mouth"
Description
Sensation of "clean mouth" assessed on a visual analogue scale from 0 to 10 where 0 indicates no sensation of clean mouth and 10 maximum sensation of clean mouth
Time Frame
5 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: 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. Exclusion Criteria: Subjects with manual inability to perform normal oral hygiene maneuvers Subjects allergic to silicone or nylon.
Facility Information:
Facility Name
School of Dentistry, The University of Florence
City
Florence
ZIP/Postal Code
50127
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of an Automatic Toothbrush

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