Nobio Antimicrobial Particles Effect in a Split Mouth Model

Not Applicable

• Conditions: Cervical Caries
• Interventions: Device: Nobio particles incorporated within Novidia Dental Bonding; Device: Filtek bond and flow composite

• Registration Number: NCT03501784
• Lead Sponsor: Nobio Ltd.

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.

Study Timeline

• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-04-17
• Study First Posted: 2018-04-18
• Status Verified: 2018-08
• Study Start: 2018-09-22
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-18
• Primary Completion: 2019-09-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novidia Dental bonding and flow	Nobio particles incorporated within Novidia Dental Bonding	Nobio particles incorporated within Novidia Dental Bonding and Flow.
Filtek bond and flow composite	Filtek bond and flow composite	standard of care class V composite restoration performed with Filtek and 3M

Primary Outcome Measures

Name	Time	Method
Occurrence and severity of adverse events related to dental care	one year	Record unanticipated adverse device-related events (UADE),Incidence and nature of serious adverse events (SAE).; Incidence and nature of adverse events

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Assuta Medical Center -Maccabident; 🇮🇱 Tel Aviv, Israel