Electric Toothbrush Efficacy in Preventing Dental Plaque Development
E-TOOTH
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 30, 2023
CompletedFirst Submitted
Initial submission to the registry
April 5, 2024
CompletedFirst Posted
Study publicly available on registry
April 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2024
CompletedMay 17, 2024
May 1, 2024
1.2 years
April 5, 2024
May 16, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
fluorescence intensity of at least 30% (ΔR30)
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)
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 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.
120 DAYS
Study Arms (2)
A Digital
EXPERIMENTALoscillating-rotating electric toothbrush group
B Manual
ACTIVE COMPARATORmanual toothbrush group
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Riccardo Polosalead
Study Sites (1)
ADDENDO
Catania, 95100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Full Professor
Study Record Dates
First Submitted
April 5, 2024
First Posted
April 10, 2024
Study Start
January 30, 2023
Primary Completion
April 29, 2024
Study Completion
April 29, 2024
Last Updated
May 17, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share