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
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
35
Nobio particles incorporated within Novidia Dental Bonding and Flow
standard of care class V composite restoration performed with Filtek and 3M
Assuta Medical Center -Maccabident
Tel Aviv, Israel
RECRUITINGOccurrence and severity of adverse events related to dental care
Record unanticipated adverse device-related events (UADE),Incidence and nature of serious adverse events (SAE). Incidence and nature of adverse events
Time frame: one year
Plaque index rate
0 -No Plaque up to 3-Abundance plaque
Time frame: one year
Replica method for bacterial count
Impression matrix sampling the tooth bio film layer
Time frame: one year
Physician assessment of cervical restoration integrity
Marginal integrity of the performed restoration
Time frame: one year
Subject and Dentist satisfaction questionnaire
satisfaction questionnaire ranging from 1(strongly disagree )to 10 (strongly agree)
Time frame: one year
Dead/Live Staining of biofilm (Cyto 9)
CSLM quantitative measurement
Time frame: one year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.