Nobio Antimicrobial Particles Effect in a Split Mouth Model

NCT03501784 | Unknown

• 1 other identifier: ND01 version 02
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Cervical Caries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Plaque index rate

  one year

• Replica method for bacterial count

  one year

• Physician assessment of cervical restoration integrity

  one year

• Subject and Dentist satisfaction questionnaire

  one year

• Dead/Live Staining of biofilm (Cyto 9)

  one year

Study Arms (2)

Novidia Dental bonding and flow

EXPERIMENTAL

Nobio particles incorporated within Novidia Dental Bonding and Flow.

Device: Nobio particles incorporated within Novidia Dental Bonding

Filtek bond and flow composite

ACTIVE COMPARATOR

standard of care class V composite restoration performed with Filtek and 3M

Device: Filtek bond and flow composite

Interventions

Nobio particles incorporated within Novidia Dental Bonding DEVICE

Nobio particles incorporated within Novidia Dental Bonding and Flow

Also known as: Device

Novidia Dental bonding and flow

Filtek bond and flow composite DEVICE

standard of care class V composite restoration performed with Filtek and 3M

Filtek bond and flow composite

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Allergic reaction to iodide.
• Pregnant or lactating women.
• Use of antiseptic mouth rinse or antibiotic up to 2 weeks before the beginning of 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.

Sponsors & Collaborators

• Nobio Ltd.: lead

Study Sites (1)

Assuta Medical Center -Maccabident

Tel Aviv, 5242321, Israel

RECRUITING

Related Publications (2)

• 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.

  PMID: 25678123 BACKGROUND

• 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.

  PMID: 21131569 RESULT

MeSH Terms

Conditions

Root Caries

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Bertrude LEV DOR, DMD

  MACCABIDENT ASSUTA

  PRINCIPAL INVESTIGATOR

• Bat sheva Levy

  Nobio Ltd.

  STUDY DIRECTOR

Central Study Contacts

Bertrude LEV DOR, DMD

CONTACT

972-54-772-0015; levdor_b@maccabi-dent.com

Bertrude LEV DOR, DMD

CONTACT

972-54-772-0015

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an exploratory, comparative, self-controlled, single blind study

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: April 18, 2018
• Study Start: September 22, 2018
• Primary Completion: September 30, 2019
• Study Completion: December 30, 2019
• Last Updated: March 18, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)