Cervical Caries Clinical Trial
Official title:
Nobio Antimicrobial Particles Effect in a Split Mouth Model
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
Status | Recruiting |
Enrollment | 35 |
Est. completion date | December 30, 2019 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. Exclusion criteria for the chosen teeth for the study: - Tooth designated for extraction in the following 6 month. - Tooth designated to have a root canal treatment. - Tooth or several teeth designated for periodontal surgery. |
Country | Name | City | State |
---|---|---|---|
Israel | Assuta Medical Center -Maccabident | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
Nobio Ltd. |
Israel,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Plaque index rate | 0 -No Plaque up to 3-Abundance plaque | one year | |
Secondary | Replica method for bacterial count | Impression matrix sampling the tooth bio film layer | one year | |
Secondary | Physician assessment of cervical restoration integrity | Marginal integrity of the performed restoration | one year | |
Secondary | Subject and Dentist satisfaction questionnaire | satisfaction questionnaire ranging from 1(strongly disagree )to 10 (strongly agree) | one year | |
Secondary | Dead/Live Staining of biofilm (Cyto 9) | CSLM quantitative measurement | one year |
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