An interventional study of U-shape Automatic Electric Toothbrush and Usual home toothbrushing procedure in Dental Plaque and Toothbrushing, sponsored by University of Florence. Completed at 1 site in Italy. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-24.
Sponsored by University of Florence · Not applicable, Interventional, and Treatment
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.
314 studies on the registry are indexed under Dental Plaque; 55 are open to participants now.
This study's enrollment of 22 is below the median of 59 across 279 interventional studies indexed under Dental Plaque.
Browse Dental Plaque studies →University of Florence is the lead sponsor of 75 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Device: U-shape Automatic Electric Toothbrush
Other: Usual home toothbrushing procedure
Other: Conventional 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.
Usual home toothbrushing procedure either with manual or electric toothbrush without the use of toothpaste.
The Conventional Electric Toothbrush will be applied for 2 minutes on the teeth of both arches without the use of toothpaste.
Full mouth plaque score
Percentage of sites that presents with plaque on the total of the sites examined (6 sites per tooth).
Time frame: Difference between pre- and post-brushing (time frame 10-15 minutes)
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
Time frame: Post-brushing (time frame 1-2 minutes)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Florence