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OpenTrials
Completed

NCT Number: NCT05594134

Efficacy of an Automatic Toothbrush

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.

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Key information

Conditions

Dental Plaque Dental Deposits Stomatognathic Diseases Tooth Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry, The University of Florence

Florence, 50127, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Automatic toothbrush with nylon bristle

Other

The automatic toothbrush with nylon bristles will be used for 10 seconds per dental arch

Automatic toothbrush with silicone bristle

Other

The automatic toothbrush with silicone bristles will be used for 10 seconds

Manual toothbrush used for 2 minutes

Other

A conventional manual toothbrush will be used for 2 minutes

Manual toothbrush used for 45 seconds

Other

A conventional manual toothbrush will be used for 45 seconds

Primary outcomes

  1. Change in full mouth plaque score

    Time frame: 5 minutes

    Difference in full mouth plaque score between before and after brushing

Secondary outcomes

  1. Perception of "clean mouth"

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2022
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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