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

Study Overview

• Status: Unknown
• Conditions: Cervical Caries
• Intervention / Treatment: Device: Nobio particles incorporated within Novidia Dental Bonding; Device: Filtek bond and flow composite

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.

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 5242321
    • Recruiting
    • Assuta Medical Center -Maccabident
    • Contact: Bertrude Lev- Dor, DMD; Phone Number: 03-03-764-4444; Email: levdor_b@maccabi-dent.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nobio Ltd.
• Investigators: Principal Investigator: Bertrude LEV DOR, DMD, MACCABIDENT ASSUTA; Study Director: Bat sheva Levy, Nobio Ltd.

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2018
• Primary Completion (Anticipated): September 30, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: March 6, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): March 18, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Root Caries
• Other Study ID Numbers: ND01 version 02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The final study results will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No