Efficacy of an Automatic Toothbrush

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of an Automatic Toothbrush With Nylon Bristles in Removing Dental Plaque: a Randomized Cross-over Study

Conditions
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Dental Plaque

Intervention / Treatment
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* Other: Automatic toothbrush with nylon bristle
* Other: Automatic toothbrush with silicone bristle
* Other: Manual toothbrush used for 2 minutes
* Other: Manual toothbrush used for 45 seconds


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automatic toothbrush with nylon bristles<br> | Other: Automatic toothbrush with nylon bristle<br>* The automatic toothbrush with nylon bristles will be used for 10 seconds per dental arch<br>|
| Active Comparator: Automatic toothbrush with silicone bristles<br> | Other: Automatic toothbrush with silicone bristle<br>* The automatic toothbrush with silicone bristles will be used for 10 seconds<br>|
| Active Comparator: Manual toothbrush used for 2 minutes<br> | Other: Manual toothbrush used for 2 minutes<br>* A conventional manual toothbrush will be used for 2 minutes<br>|
| Active Comparator: Manual toothbrush used for 45 seconds<br> | Other: Manual toothbrush used for 45 seconds<br>* A conventional manual toothbrush will be used for 45 seconds<br>|
| No Intervention: No brushing<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in full mouth plaque score | Difference in full mouth plaque score between before and after brushing | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of clean mouth | 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 | 5 minutes |