Efficacy of an Automatic Toothbrush

University of Florence (UNIFI)

Status: Completed

Conditions: Dental Plaque

Treatments: Other: Automatic toothbrush with silicone bristle; Other: Automatic toothbrush with nylon bristle; Other: Manual toothbrush used for 2 minutes; Other: Manual toothbrush used for 45 seconds

Study type: Interventional

Funder types: Other

Identifiers

NCT05594134

IUFET2

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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25 participants in 5 patient groups

Automatic toothbrush with nylon bristles

Experimental group

Treatment:

Other: Automatic toothbrush with nylon bristle

Automatic toothbrush with silicone bristles

Active Comparator group

Treatment:

Other: Automatic toothbrush with silicone bristle

Manual toothbrush used for 2 minutes

Active Comparator group

Treatment:

Other: Manual toothbrush used for 2 minutes

Manual toothbrush used for 45 seconds

Active Comparator group

Treatment:

Other: Manual toothbrush used for 45 seconds

No brushing

No Intervention group