Lesion Progression of Approximal Caries After Resin Infiltration
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|ClinicalTrials.gov Identifier: NCT02191943|
Recruitment Status : Withdrawn
First Posted : July 16, 2014
Last Update Posted : January 26, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Proximal Caries||Device: Duraphat Device: Icon approximal caries infiltration kit||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Long-term Bi-center Trial to Compare the Radiological Cavity Progression of Approximal Caries Following Infiltration or Standard Treatment|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2019|
|Active Comparator: Control (fluoride varnish)||
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.
Other Name: fluoride varnish
|Experimental: resin infiltration (Icon)||
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:
Other Name: resin infiltration
- progression of non-cavitated proximal caries lesions [ Time Frame: up to 36 months ]preventing the progression of non-cavitated approximal lesions in comparison to conventional non invasive treatment; lesion progression will be monitored by annual bitewings and comparison to baseline lesion size
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191943
|United States, Oregon|
|OHSU School of Dentistry / Department of Restorative Dentistry Oregon Health and Science University (OHSU)|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Silke Jacker-Guhr, Dr.||Department of Conservtive Dentistry, Periodontology and PreventiveDentistry Hannover Medical School|
|Principal Investigator:||Anne-Kathrin Lührs, Dr.||Department of Conservtive Dentistry, Periodontology and PreventiveDentistry Hannover Medical School|
|Study Chair:||Jack L Ferracane, Prof.||OHSU School of Dentistry / Department of Restorative Dentistry Oregon Health and Science University (OHSU)|