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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 fluoride.

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 one with fluoride as control. Study duration is 24 months. For assessment x-ray pictures, Diagnodent Pen and DiagnoCam is 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: Additional benefit of a second Curodont Repair application [ Time Frame: Day 720 ]

The secondary efficacy outcome is the difference of the change in the opaqueness of the carious lesion on the x-ray picture from Day 360 to Day 720 between test and control group.


Original Secondary Outcome: Same as current

Information By: Credentis AG

Dates:
Date Received: March 21, 2014
Date Started: July 2014
Date Completion: December 2018
Last Updated: January 30, 2017
Last Verified: January 2017