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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novidia Dental bonding and flow | Experimental | Nobio particles incorporated within Novidia Dental Bonding and Flow. |
|
| Filtek bond and flow composite | Active Comparator | standard of care class V composite restoration performed with Filtek and 3M |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nobio particles incorporated within Novidia Dental Bonding | Device | Nobio particles incorporated within Novidia Dental Bonding and Flow |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque index rate | 0 -No Plaque up to 3-Abundance plaque | one year |
| Replica method for bacterial count | Impression matrix sampling the tooth bio film layer |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria for the chosen teeth for the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bertrude LEV DOR, DMD | Contact | 972-54-772-0015 | levdor_b@maccabi-dent.com | |
| Bertrude LEV DOR, DMD | Contact | 972-54-772-0015 |
| Name | Affiliation | Role |
|---|---|---|
| Bertrude LEV DOR, DMD | MACCABIDENT ASSUTA | Principal Investigator |
| Bat sheva Levy | Nobio Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assuta Medical Center -Maccabident | Recruiting | Tel Aviv | 5242321 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25678123 | Background | Atar-Froyman L, Sharon A, Weiss EI, Houri-Haddad Y, Kesler-Shvero D, Domb AJ, Pilo R, Beyth N. Anti-biofilm properties of wound dressing incorporating nonrelease polycationic antimicrobials. Biomaterials. 2015 Apr;46:141-8. doi: 10.1016/j.biomaterials.2014.12.047. Epub 2015 Jan 28. | |
| 21131569 | Result | Beyth N, Yudovin-Farber I, Perez-Davidi M, Domb AJ, Weiss EI. Polyethyleneimine nanoparticles incorporated into resin composite cause cell death and trigger biofilm stress in vivo. Proc Natl Acad Sci U S A. 2010 Dec 21;107(51):22038-43. doi: 10.1073/pnas.1010341107. Epub 2010 Dec 3. |
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The final study results will be shared
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| ID | Term |
|---|---|
| D017213 | Root Caries |
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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This is an exploratory, comparative, self-controlled, single blind study
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|
| Filtek bond and flow composite | Device | standard of care class V composite restoration performed with Filtek and 3M |
|
| one year |
| Physician assessment of cervical restoration integrity | Marginal integrity of the performed restoration | one year |
| Subject and Dentist satisfaction questionnaire | satisfaction questionnaire ranging from 1(strongly disagree )to 10 (strongly agree) | one year |
| Dead/Live Staining of biofilm (Cyto 9) | CSLM quantitative measurement | one year |