Nobio Antimicrobial Particles Effect in a Split Mouth Model

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-22

Study Completion Date

2019-12-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Cervical Caries

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Novidia Dental bonding and flow

Nobio particles incorporated within Novidia Dental Bonding and Flow.

Group Type EXPERIMENTAL

Nobio particles incorporated within Novidia Dental Bonding

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

Filtek bond and flow composite

Intervention Type DEVICE

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

Interventions

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Nobio particles incorporated within Novidia Dental Bonding

Nobio particles incorporated within Novidia Dental Bonding and Flow

Intervention Type DEVICE

Filtek bond and flow composite

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

Intervention Type DEVICE

Other Intervention Names

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Device

Eligibility Criteria

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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.

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No