Efficacy of an U-shape Automatic Electric Toothbrush in Plaque Removal

Dental Plaque Clinical Trial

Official title:

Efficacy of an U-shape Automatic Electric Toothbrush in Plaque Removal: a Crossover Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119583
• Other study ID #: IUFET1
• Status: Completed
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: February 14, 2020

Study information

• Verified date: March 2020
• Source: University of Florence
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 14, 2020
• Est. primary completion date: February 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Plaque
• Toothbrushing

Intervention

Device:
• U-shape Automatic Electric Toothbrush
The U-shape Automatic Electric Toothbrush will be applied for 30-45 seconds on the teeth of both arches without the use of toothpaste.

Other:
• Usual home toothbrushing procedure
Usual home toothbrushing procedure either with manual or electric toothbrush without the use of toothpaste.
• Conventional Electric Toothbrush
The Conventional Electric Toothbrush will be applied for 2 minutes on the teeth of both arches without the use of toothpaste.

Locations

Country	Name	City	State
Italy	SOD Odontostomatologia	Firenze

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Full mouth plaque score	Percentage of sites that presents with plaque on the total of the sites examined (6 sites per tooth).	Difference between pre- and post-brushing (time frame 10-15 minutes)
Secondary	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	Post-brushing (time frame 1-2 minutes)