Electric Toothbrush Efficacy in Preventing Dental Plaque Development (E-TOOTH)

May 16, 2024 updated by: Riccardo Polosa

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catania, Italy, 95100
        • ADDENDO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A Digital
oscillating-rotating electric toothbrush group
Behavioral: oscillating toothbrush
oscillating toothbrush
Active Comparator: B Manual
manual toothbrush group
Behavioral: standard manual toothbrush
standard manual toothbrush

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fluorescence intensity of at least 30% (ΔR30)
Time Frame: 120 DAYS
1) 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,
120 DAYS
the fluorescence intensity of at least 120% (ΔR120)
Time Frame: 120 DAYS
2) 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.
120 DAYS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3) the simple oral hygiene (SOH) scoring - this score is calculated by the proprietary software and provides an estimate of the degree of gingival inflammation.
120 DAYS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riccardo Polosa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Actual)

April 29, 2024

Study Completion (Actual)

April 29, 2024

Study Registration Dates

First Submitted

April 5, 2024

First Submitted That Met QC Criteria

April 5, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORAL1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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