Clinical trial NCT03501784: Nobio Antimicrobial Particles Effect in a Split Mouth Model
Official title: Nobio Antimicrobial Particles Effect in a Split Mouth Model
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Caries
Lead sponsor: Nobio Ltd.
Sponsor class: INDUSTRY
First posted: 2018-04-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an exploratory, comparative, self-controlled, single blind study
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence and severity of adverse events related to dental care
timeFrame: one year
Secondary outcomes:
measure: Plaque index rate
timeFrame: one year
measure: Replica method for bacterial count
timeFrame: one year
measure: Physician assessment of cervical restoration integrity
timeFrame: one year
measure: Subject and Dentist satisfaction questionnaire
timeFrame: one year
measure: Dead/Live Staining of biofilm (Cyto 9)
timeFrame: one year
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Assuta Medical Center -Maccabident
Study officials:
affiliation: MACCABIDENT ASSUTA
name: Bertrude LEV DOR, DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nobio Ltd.
name: Bat sheva Levy
role: STUDY_DIRECTOR
References:
citation: 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.
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.1010341107. Epub 2010 Dec 3.