Efficacy of an Automatic Toothbrush

Efficacy of an Automatic Toothbrush With Nylon Bristles in Removing Dental Plaque: a Randomized Cross-over Study

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.

Study Overview

• Status: Completed
• Conditions: Dental Plaque
• Intervention / Treatment: Other: Automatic toothbrush with nylon bristle; Other: Automatic toothbrush with silicone bristle; Other: Manual toothbrush used for 2 minutes; Other: Manual toothbrush used for 45 seconds

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Florence, Italy, 50127
    • School of Dentistry, The University of Florence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 26 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Automatic toothbrush with nylon bristles	Other: Automatic toothbrush with nylon bristle; The automatic toothbrush with nylon bristles will be used for 10 seconds per dental arch
Active Comparator: Automatic toothbrush with silicone bristles	Other: Automatic toothbrush with silicone bristle; The automatic toothbrush with silicone bristles will be used for 10 seconds
Active Comparator: Manual toothbrush used for 2 minutes	Other: Manual toothbrush used for 2 minutes; A conventional manual toothbrush will be used for 2 minutes
Active Comparator: Manual toothbrush used for 45 seconds	Other: Manual toothbrush used for 45 seconds; A conventional manual toothbrush will be used for 45 seconds
No Intervention: No brushing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in full mouth plaque score	Difference in full mouth plaque score between before and after brushing	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 minutes

Collaborators and Investigators

• Sponsor: University of Florence

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Actual): December 21, 2022
• Study Completion (Actual): December 21, 2022

Study Registration Dates

• First Submitted: October 21, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque
• Other Study ID Numbers: IUFET2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No