Nobio Antimicrobial Particles Effect in a Split Mouth Model

Nobio

Status: Unknown

Conditions: Cervical Caries

Treatments: Device: Nobio particles incorporated within Novidia Dental Bonding; Device: Filtek bond and flow composite

Study type: Interventional

Funder types: Industry

Identifiers

NCT03501784

ND01 version 02

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 2 patient groups

Novidia Dental bonding and flow

Experimental group

Description:

Nobio particles incorporated within Novidia Dental Bonding and Flow.

Treatment:

Device: Nobio particles incorporated within Novidia Dental Bonding

Filtek bond and flow composite

Active Comparator group

Description:

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

Treatment:

Device: Filtek bond and flow composite