Efficacy of an Automatic Toothbrush

Not Applicable

Completed

• Conditions: Dental Plaque
• Interventions: Other: Manual toothbrush used for 2 minutes; Other: Automatic toothbrush with nylon bristle; Other: Automatic toothbrush with silicone bristle; Other: Manual toothbrush used for 45 seconds

• Registration Number: NCT05594134
• Lead Sponsor: University of Florence

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-21
• Study First Submitted QC: 2022-10-21
• Study First Posted: 2022-10-26
• Study Start: 2022-11-07
• Primary Completion: 2022-12-21
• Study Completion: 2022-12-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Manual toothbrush used for 2 minutes	Manual toothbrush used for 2 minutes	-
Automatic toothbrush with nylon bristles	Automatic toothbrush with nylon bristle	-
Automatic toothbrush with silicone bristles	Automatic toothbrush with silicone bristle	-
Manual toothbrush used for 45 seconds	Manual toothbrush used for 45 seconds	-

Primary Outcome Measures

Name	Time	Method
Change in full mouth plaque score	5 minutes	Difference in full mouth plaque score between before and after brushing

Secondary Outcome Measures

Name	Time	Method
Perception of "clean mouth"	5 minutes	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

Trial Locations

Locations (1)

School of Dentistry, The University of Florence; 🇮🇹 Florence, Italy