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Nobio Antimicrobial Particles Effect in a Split Mouth Model

Primary Purpose

Cervical Caries

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Nobio particles incorporated within Novidia Dental Bonding
Filtek bond and flow composite
Sponsored by
Nobio Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Caries

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assuta Medical Center -MaccabidentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Novidia Dental bonding and flow

Filtek bond and flow composite

Arm Description

Nobio particles incorporated within Novidia Dental Bonding and Flow.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Plaque index rate
0 -No Plaque up to 3-Abundance plaque
Replica method for bacterial count
Impression matrix sampling the tooth bio film layer
Physician assessment of cervical restoration integrity
Marginal integrity of the performed restoration
Subject and Dentist satisfaction questionnaire
satisfaction questionnaire ranging from 1(strongly disagree )to 10 (strongly agree)
Dead/Live Staining of biofilm (Cyto 9)
CSLM quantitative measurement

Full Information

First Posted
March 6, 2018
Last Updated
March 14, 2019
Sponsor
Nobio Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03501784
Brief Title
Nobio Antimicrobial Particles Effect in a Split Mouth Model
Official Title
Nobio Antimicrobial Particles Effect in a Split Mouth Model
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 22, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nobio Ltd.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is an exploratory, comparative, self-controlled, single blind study
Masking
Participant
Allocation
Non-Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Novidia Dental bonding and flow
Arm Type
Experimental
Arm Description
Nobio particles incorporated within Novidia Dental Bonding and Flow.
Arm Title
Filtek bond and flow composite
Arm Type
Active Comparator
Arm Description
standard of care class V composite restoration performed with Filtek and 3M
Intervention Type
Device
Intervention Name(s)
Nobio particles incorporated within Novidia Dental Bonding
Other Intervention Name(s)
Device
Intervention Description
Nobio particles incorporated within Novidia Dental Bonding and Flow
Intervention Type
Device
Intervention Name(s)
Filtek bond and flow composite
Intervention Description
standard of care class V composite restoration performed with Filtek and 3M
Primary Outcome Measure Information:
Title
Occurrence and severity of adverse events related to dental care
Description
Record unanticipated adverse device-related events (UADE),Incidence and nature of serious adverse events (SAE). Incidence and nature of adverse events
Time Frame
one year
Secondary Outcome Measure Information:
Title
Plaque index rate
Description
0 -No Plaque up to 3-Abundance plaque
Time Frame
one year
Title
Replica method for bacterial count
Description
Impression matrix sampling the tooth bio film layer
Time Frame
one year
Title
Physician assessment of cervical restoration integrity
Description
Marginal integrity of the performed restoration
Time Frame
one year
Title
Subject and Dentist satisfaction questionnaire
Description
satisfaction questionnaire ranging from 1(strongly disagree )to 10 (strongly agree)
Time Frame
one year
Title
Dead/Live Staining of biofilm (Cyto 9)
Description
CSLM quantitative measurement
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bertrude LEV DOR, DMD
Phone
972-54-772-0015
Email
levdor_b@maccabi-dent.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bertrude LEV DOR, DMD
Phone
972-54-772-0015
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrude LEV DOR, DMD
Organizational Affiliation
MACCABIDENT ASSUTA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bat sheva Levy
Organizational Affiliation
Nobio Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Assuta Medical Center -Maccabident
City
Tel Aviv
ZIP/Postal Code
5242321
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrude Lev- Dor, DMD
Phone
03-03-764-4444
Email
levdor_b@maccabi-dent.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The final study results will be shared
Citations:
PubMed Identifier
25678123
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.
Results Reference
background
PubMed Identifier
21131569
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.
Results Reference
result

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Nobio Antimicrobial Particles Effect in a Split Mouth Model

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