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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06358482
Other study ID # ORAL1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 30, 2023
Est. completion date April 29, 2024

Study information

Verified date May 2024
Source Universita degli Studi di Catania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date April 29, 2024
Est. primary completion date April 29, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
oscillating toothbrush
oscillating toothbrush
standard manual toothbrush
standard manual toothbrush

Locations

Country Name City State
Italy ADDENDO Catania

Sponsors (1)

Lead Sponsor Collaborator
Riccardo Polosa

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary fluorescence intensity of at least 30% (?R30) 1) the percentage of the total tooth surface showing an increase in the fluorescence intensity of at least 30% (?R30) - this indicates the total area of mature dental plaque detected, 120 DAYS
Primary the fluorescence intensity of at least 120% (?R120) 2) the percentage of the total tooth surface showing an increase in the fluorescence intensity of at least 120% (?R120) - 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 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. 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
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