Dental Plaque, Toothbrushing
Conditions
Brief 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.
Interventions
DEVICEU-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.
OTHERUsual home toothbrushing procedure
Usual home toothbrushing procedure either with manual or electric toothbrush without the use of toothpaste.
OTHERConventional Electric Toothbrush
The Conventional Electric Toothbrush will be applied for 2 minutes on the teeth of both arches without the use of toothpaste.
Sponsors
University of Florence
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Full mouth plaque score | Difference between pre- and post-brushing (time frame 10-15 minutes) | Percentage of sites that presents with plaque on the total of the sites examined (6 sites per tooth). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feeling of clean mouth | Post-brushing (time frame 1-2 minutes) | Visual analogue scale from 0 to 10 where 0 indicates no feeling of clean mouth and 10 maximum feeling of clean mouth |
Countries
Italy
Outcome results
None listed