Clinical Trial: Effect of Curodont Repair in Patients With Early Approximal Carious Lesions

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Curodont Repair in Patients With Early Approximal Carious Lesions: A Mono-centre, Controlled, Single-blinded, Randomised, Post-marketing Study

Brief Summary: The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the treatment of early approximal carious lesions compared to no treatment.

Detailed Summary: All study participants must have two early approximal carious lesions in need of a treatment but not of an invasive treatment (split-mouth design). One lesion will be treated with Curodont Repair and the other will not undergo a treatment as control. Study duration is 12 months. For assessment x-ray pictures are used.
Sponsor: Credentis AG

Current Primary Outcome: Opaqueness on X-Ray [ Time Frame: Day 360 ]

The primary efficacy outcome is the difference of the change in the opaqueness of the carious lesion on the x-ray picture from Day 0 to Day 365 between test and control group.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Credentis AG

Dates:
Date Received: April 17, 2014
Date Started: April 2013
Date Completion:
Last Updated: January 26, 2016
Last Verified: January 2016