Efficacy of an Automatic Toothbrush

Dental Plaque Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05594134
• Other study ID #: IUFET2
• Status: Completed
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: December 21, 2022

Study information

• Verified date: April 2023
• Source: University of Florence
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 21, 2022
• Est. primary completion date: December 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Plaque

Intervention

Other:
• Automatic toothbrush with nylon bristle
The automatic toothbrush with nylon bristles will be used for 10 seconds per dental arch
• Automatic toothbrush with silicone bristle
The automatic toothbrush with silicone bristles will be used for 10 seconds
• Manual toothbrush used for 2 minutes
A conventional manual toothbrush will be used for 2 minutes
• Manual toothbrush used for 45 seconds
A conventional manual toothbrush will be used for 45 seconds

Locations

Country	Name	City	State
Italy	School of Dentistry, The University of Florence	Florence

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in full mouth plaque score	Difference in full mouth plaque score between before and after brushing	5 minutes
Secondary	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