An interventional study of Nobio particles incorporated within Novidia Dental Bonding and Filtek bond and flow composite in Cervical Caries, sponsored by Nobio Ltd.. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-03-18.
Sponsored by Nobio Ltd. · Not applicable, Interventional, and Prevention
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.
39 studies on the registry are indexed under Root Caries; 14 are open to participants now.
This study's planned enrollment of 35 is below the median of 62 across 35 interventional studies indexed under Root Caries.
Browse Root Caries studies →This is the only study on the registry with Nobio Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Exclusion criteria for the chosen teeth for the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nobio particles incorporated within Novidia Dental Bonding and Flow.
Device: Nobio particles incorporated within Novidia Dental Bonding
standard of care class V composite restoration performed with Filtek and 3M
Device: Filtek bond and flow composite
Nobio particles incorporated within Novidia Dental Bonding and Flow
Also known as: Device
standard of care class V composite restoration performed with Filtek and 3M
Occurrence 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
Plan to share: No — The final study results will be shared
Started Sep 2018 (actual). Primary completion is estimated for Sep 2019, 12 months after the start.
Of 21 interventional studies with no phase under Root Caries, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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