Dental Plaque
Conditions
Brief 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.
Interventions
OTHERAutomatic toothbrush with nylon bristle
The automatic toothbrush with nylon bristles will be used for 10 seconds per dental arch
OTHERAutomatic toothbrush with silicone bristle
The automatic toothbrush with silicone bristles will be used for 10 seconds
OTHERManual toothbrush used for 2 minutes
A conventional manual toothbrush will be used for 2 minutes
OTHERManual toothbrush used for 45 seconds
A conventional manual toothbrush will be used for 45 seconds
Sponsors
University of Florence
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in full mouth plaque score | 5 minutes | Difference in full mouth plaque score between before and after brushing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perception of clean mouth | 5 minutes | 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 |
Countries
Italy
Outcome results
None listed