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NCT04119583

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

Completed NA Last updated 24 March 2020
What this trial tests

NA trial testing U-shape Automatic Electric Toothbrush in Dental Plaque in 22 participants. Completed in 14 February 2020.

Timeline
20 January 2020
Primary endpoint
14 February 2020
14 February 2020

Quick facts

Lead sponsorUniversity of Florence
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposetreatment
Enrollment22
Start date20 January 2020
Primary completion14 February 2020
Estimated completion14 February 2020
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

University of Florence

Who can join

Adults 18 to 30, any sex, with Dental Plaque or Toothbrushing. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Efficacy of a U-Shaped Automatic Electric Toothbrush in Dental Plaque Removal: A Cross-Over Randomized Controlled Trial.
    Nieri M, Giuntini V, Pagliaro U, Giani M, et al · · 2020 · cited 14× · PMID 32605239 · DOI 10.3390/ijerph17134649

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Other recruiting trials for Dental Plaque

Currently open trials in the same condition.

Other University of Florence trials

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Data sources for this page

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