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NCT Number: NCT04119583

Efficacy of an U-shape Automatic Electric Toothbrush in Plaque Removal

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SOD Odontostomatologia

Florence, 50127, Italy

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

U-shape Automatic Electric Toothbrush

Device

The U-shape Automatic Electric Toothbrush will be applied for 30-45 seconds on the teeth of both arches without the use of toothpaste.

Usual home toothbrushing procedure

Other

Usual home toothbrushing procedure either with manual or electric toothbrush without the use of toothpaste.

Conventional Electric Toothbrush

Other

The Conventional Electric Toothbrush will be applied for 2 minutes on the teeth of both arches without the use of toothpaste.

Primary outcomes

  1. Full mouth plaque score

    Time frame: 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 outcomes

  1. Feeling of "clean mouth"

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Registry information

Official study title

Efficacy of an U-shape Automatic Electric Toothbrush in Plaque Removal: a Crossover Randomized Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 8, 2019
Registry last updated
Mar 24, 2020

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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