Nobio Clinical Study - Demineralization Prevention With a New Antibacterial Restorative Composite

NCT04059250 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-03-12

Study results available
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Summary

Nobio has developed dental restorative materials with long term antibacterial properties in order to fight recurrent decay/caries around restorations. These composites with incorporated non-leaching antibacterial agents might overcome the vicious circle of newly developed cavities around freshly placed fillings.

The investigators will ask lower partial denture wearers to allow them to place a "gap model" with the Nobio-composite and enamel slab in one denture flange. In the other denture flange a gap model with a standard composite will be placed as control. In the laboratory the investigators will test with established methods for demineralization/caries prevention in the test and control enamel slabs, respectively.

Conditions

  • Dental Caries
  • Denture, Partial, Removable

Interventions

DEVICE

Nobio composite

Nobio has developed a bactericidal composite, which does not leak out the bactericidal nano fillers

DEVICE

traditional composite

traditional composite which has no bactericidal activities

Sponsors & Collaborators

Principal Investigators

  • Peter Rechmann · UCSF - School of Dentistry - Preventive and Restorative Dental Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-28
Primary Completion
2020-03-10
Completion
2020-03-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04059250 on ClinicalTrials.gov