Nobio Antimicrobial Particles Effect in a Split Mouth Model

Cervical Caries Clinical Trial

Official title:

Nobio Antimicrobial Particles Effect in a Split Mouth Model

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03501784
• Other study ID #: ND01 version 02
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: August 2018
• Source: Nobio Ltd.
• Contact: Bertrude LEV DOR, DMD
• Phone: 972-54-772-0015
• Email: levdor_b[@]maccabi-dent.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Caries
• Root Caries

Intervention

Device:
• Nobio particles incorporated within Novidia Dental Bonding
Nobio particles incorporated within Novidia Dental Bonding and Flow
• Filtek bond and flow composite
standard of care class V composite restoration performed with Filtek and 3M

Locations

Country	Name	City	State
Israel	Assuta Medical Center -Maccabident	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Nobio Ltd.

Country where clinical trial is conducted

Israel, 

References & 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. — View 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. — View Citation

Outcome

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