Cervical Caries
Conditions
Brief summary
The study purpose is to evaluate the antimicrobial effect of Nobio particles incorporated within Novidia Dental Bonding and Flowable Composite versus standard of care within a split mouth model.The study population will include 35 subjects considered to be at high risk for cervical caries and affected by uncontrolled plaque accumulation
Detailed description
An exploratory, comparative, self-controlled single blinded interventional study. Intended to evaluate the antimicrobial effect of Nobio particles incorporated within Novidia Dental Bonding and Flowable composite versus Filtek bond and flow composite within a split mouth model.The study population (N=35) will be high risk population for cervical caries (with at least 2 carious cavities in the mouth) affected by uncontrolled plaque accumulation.Each subject will serve in this model as his own control.On one side the Novidia intervention will be made and on the contralateral side the Filtek intervention.
Interventions
DEVICENobio particles incorporated within Novidia Dental Bonding
Nobio particles incorporated within Novidia Dental Bonding and Flow
DEVICEFiltek bond and flow composite
standard of care class V composite restoration performed with Filtek and 3M
Sponsors
Nobio Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
This is an exploratory, comparative, self-controlled, single blind study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female over 18 years of age. * Requires two cervical restorations or the exchange of existing ones * Subject has poor oral hygiene and at high risk for plaque accumulation. * Subject able and willing to comply with study visits and Follow up visits and signed the informed consent.
Exclusion criteria
* Allergic reaction to iodide. * Pregnant or lactating women. * Use of antiseptic mouth rinse or antibiotic up to 2 weeks before the beginning of study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence and severity of adverse events related to dental care | one year | Record unanticipated adverse device-related events (UADE),Incidence and nature of serious adverse events (SAE). Incidence and nature of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque index rate | one year | 0 -No Plaque up to 3-Abundance plaque |
| Replica method for bacterial count | one year | Impression matrix sampling the tooth bio film layer |
| Physician assessment of cervical restoration integrity | one year | Marginal integrity of the performed restoration |
| Subject and Dentist satisfaction questionnaire | one year | satisfaction questionnaire ranging from 1(strongly disagree )to 10 (strongly agree) |
| Dead/Live Staining of biofilm (Cyto 9) | one year | CSLM quantitative measurement |
Countries
Israel
Contacts
Primary ContactBertrude LEV DOR, DMD
Backup ContactBertrude LEV DOR, DMD
Outcome results
None listed