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Completed

NCT Number: NCT06358482

Electric Toothbrush Efficacy in Preventing Dental Plaque Development

The present study will be the first to compared dental plaque quantitation between an oscillating-rotating electric toothbrush and a manual toothbrush with a new QLF technology.

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Key information

Conditions

Dental Plaque Calculi Calculus, Dental Dental Calculus Dental Deposits Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ADDENDO

Catania, 95100, Italy

About this study

This is a randomized controlled trial of 12-weeks duration designed to assess whether a new commercially available oscillating-rotating electric toothbrush can objectively improve dental plaque parameters obtained via light induced fluorescence (QLF) technology. The study will be conducted in a dental clinic in Italy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy adult (aged 18-50 years)
  • non-smokers
  • without clinical signs of periodontitis with at least 10 natural anterior teeth in total (cuspid to cuspid and lower and upper jaw).

Exclusion criteria

  • significant oral soft tissue pathology or any type of gingival overgrowth other than plaque-induced gingivitis,
  • with fixed and removable orthodontic appliances or removable dentures,
  • with any other medical condition that, in the opinion of the principal investigator, would jeopardize the participant's safety or diminish the validity of study results

Treatment and study plan

oscillating toothbrush

Behavioral

oscillating toothbrush

standard manual toothbrush

Behavioral

standard manual toothbrush

Primary outcomes

  1. fluorescence intensity of at least 30% (ΔR30)

    Time frame: 120 DAYS

    • the percentage of the total tooth surface showing an increase in the fluorescence intensity of at least 30% (ΔR30) - this indicates the total area of mature dental plaque detected,

  2. the fluorescence intensity of at least 120% (ΔR120)

    Time frame: 120 DAYS

    • the percentage of the total tooth surface showing an increase in the fluorescence intensity of at least 120% (ΔR120) - this reveals just areas of greater level of plaque thickness/maturation (i.e. calculus/tartar) within the total area of mature dental plaque detected.

Secondary outcomes

  1. oral hygiene (SOH) scoring, The score can be from 0, 1, .. to 5. A SOH value of 0 indicates no plaque, and 5 is the maximum and stands for maximum plaque teeth coverage an is the worst state.

    Time frame: 120 DAYS

    • the simple oral hygiene (SOH) scoring - this score is calculated by the proprietary software and provides an estimate of the degree of gingival inflammation.

Sponsors and collaborators

Lead sponsor

Riccardo Polosa

Other

Registry information

Official study title

Electric Toothbrush Efficacy in Preventing Dental Plaque Development: A RCT Using QLF Technology

Acronym: E-TOOTH

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 10, 2024
Registry last updated
May 17, 2024

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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