Calculus, Dental, Dental Plaque
Conditions
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
Interventions
BEHAVIORALoscillating toothbrush
oscillating toothbrush
BEHAVIORALstandard manual toothbrush
standard manual toothbrush
Sponsors
Riccardo Polosa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Outcome results
None listed