Clinical Trial: Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions: A Mono-centre, Split-mouth, Double-blinded, Placebo Controlled, Rand
Brief Summary: The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the treatment of early buccal carious lesions compared to placebo.
Detailed Summary: All study participants must have two early class V 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 placebo as control (single application). 3 months later fluoride (Duraphat) will be applied on both lesions. Study duration is 9 months. For assessment visual and tactile evaluation, pictures, ECM, Diagnodent Pen, Canary System, VAS is used.
Sponsor: Credentis AG
Current Primary Outcome: The primary efficacy outcome is the difference of the change in the lesion size assessed by morphometry (standardised pictures) between investigational medical device and placebo group. [ Time Frame: D0, D30, D90, D270 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Difference in the change of ECM values between investigational medical device and placebo group. [ Time Frame: D0, D30, D90, D180, D270 ]
- Difference in the change of Diagnodent Pen values between investigational medical device and placebo group. [ Time Frame: D0, D30, D90, D180, D270 ]
- Difference in the change of Canary System values between investigational medical device and placebo group. [ Time Frame: D0, D30, D90, D180, D270 ]
- Change in lesion's progression assessed by VAS between investigational medical device and placebo group. [ Time Frame: D0, D30, D90, D180, D270 ]
- Cavitation rate between investigational medical device and placebo group. [ Time Frame: D0, D30, D90, D180, D270 ]
Original Secondary Outcome: Same as current
Information By: Credentis AG
Dates:
Date Received: December 19, 2013
Date Started: September 2013
Date Completion:
Last Updated: January 26, 2016
Last Verified: January 2016