Lesion Progression of Approximal Caries After Resin Infiltration

Summary

The aim of the planned in-vivo trial is to investigate the effectiveness of the caries infiltration technique for the repression of caries progression.

Within the framework of this investigation it is intended that the hypothesis to be substantiated is that carious cavities, which have been treated with the caries infiltration technique, exhibit significantly reduced radiological progression than those cavities that have been treated using standard preventive treatments.

In this multicenter trial, a total of 90 test subjects are included and 45 test subjects at each institution are to be treated with both, the infiltration technique and using conventional fluoridation treatment in different sides of the mouth ("split-mouth design").

The anticipated result of this trial shall deliver information on the long-term effectiveness of caries infiltration to prevent the progression of existing approximal carious lesions, and thereby enable an improvement in caries prevention within the scope of dental treatment.

Conditions

• Proximal Caries

Interventions

DEVICE

Duraphat

The subjects in the control group will be the subject of personalized oral hygiene instructions on the basis of obtained indices, and will also receive a professional prophylaxis. Following this, the surfaces of the teeth in the control group involved in the trial will be treated with a fluoride varnish (Duraphat®) that will be applied with a brush to all surfaces of the teeth, working the varnish approximally with the brush. This treatment will be repeated in the comparative group at each follow-up appointment.

DEVICE

Icon approximal caries infiltration kit

Carious lesions in the teeth in the test group shall be treated with the infiltrant ICON® according to the manufacturer's instructions. Step by step instructions for application are as follows:

Sponsors & Collaborators

• Dep. Conservtive Dentistry, Periodontology and Preventive Dentistry Hannover

  collaborator UNKNOWN

• Oregon Health and Science University

  collaborator OTHER

• DMG Dental Material Gesellschaft mbH

  lead INDUSTRY

Principal Investigators

• Silke Jacker-Guhr, Dr. · Department of Conservtive Dentistry, Periodontology and PreventiveDentistry Hannover Medical School

• Anne-Kathrin Lührs, Dr. · Department of Conservtive Dentistry, Periodontology and PreventiveDentistry Hannover Medical School

• Jack L Ferracane, Prof. · OHSU School of Dentistry / Department of Restorative Dentistry Oregon Health and Science University (OHSU)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-11-30

Primary Completion

2015-12-31

Completion

2019-12-31

Countries

• United States

Study Locations