Electric Toothbrush Efficacy in Preventing Dental Plaque Development

Not Applicable

Completed

• Conditions: Dental Plaque; Calculus, Dental

• Registration Number: NCT06358482
• Lead Sponsor: Riccardo Polosa

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.

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 Timeline

• Study Start: 2023-01-30
• Study First Submitted: 2024-04-05
• Study First Submitted QC: 2024-04-05
• Study First Posted: 2024-04-10
• Primary Completion: 2024-04-29
• Study Completion: 2024-04-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
fluorescence intensity of at least 30% (ΔR30)	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,
the fluorescence intensity of at least 120% (ΔR120)	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.

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

ADDENDO; 🇮🇹 Catania, Italy