Nobio Antimicrobial Particles Effect in a Split Mouth Model

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Nobio Antimicrobial Particles Effect in a Split Mouth Model

Conditions
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Cervical Caries

Intervention / Treatment
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* Device: Nobio particles incorporated within Novidia Dental Bonding
* Device: Filtek bond and flow composite


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is an exploratory, comparative, self-controlled, single blind study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novidia Dental bonding and flow<br>Nobio particles incorporated within Novidia Dental Bonding and Flow. | Device: Nobio particles incorporated within Novidia Dental Bonding<br>* Nobio particles incorporated within Novidia Dental Bonding and Flow<br>* Other names: Device;|
| Active Comparator: Filtek bond and flow composite<br>standard of care class V composite restoration performed with Filtek and 3M | Device: Filtek bond and flow composite<br>* standard of care class V composite restoration performed with Filtek and 3M<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |