Electric Toothbrush Efficacy in Preventing Dental Plaque Development

Dental Plaque Clinical Trial

— E-TOOTH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06358482
• Other study ID #: ORAL1
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: April 2024
• Source: Universita degli Studi di Catania
• Contact: Antonio Pacino, MD
• Phone: 095 219 1853
• Email: info[@]addendo.net
• Is FDA regulated: No
• 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: Recruiting
• Enrollment: 100
• Est. completion date: July 30, 2024
• Est. primary completion date: April 30, 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

Related Conditions & MeSH terms

• Calculi
• Calculus, Dental
• Dental Calculus
• Dental Plaque

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