A Randomized Controlled Clinical Trial to Evaluate Safety and Effectiveness of CAF + Mucograft® Compared to CAF Alone in Patients With Gingival Recessions (MCT-Recession)
The purpose of this multi-center study is to determine the efficacy and safety of Mucograft® in combination with the coronally advanced flap (CAF) for the treatment of gingival recessions. It is assumed that the CAF combined with Mucograft® will result in improved outcome in terms percentage of root coverage and soft tissue thickness in comparison to CAF alone (control).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Clinical Trial to Evaluate Safety and Effectiveness of CAF + Mucograft® Compared to CAF Alone in Patients With Gingival Recessions.|
- percentage of root coverage [ Time Frame: 6 month ] [ Designated as safety issue: No ]
- gingival thickness [ Time Frame: 6 month ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Study Completion Date:||January 2012|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Mucograft + CAF
Mucograft in combination with coronally advanced flap (CAF)
Collagen Matrix for soft tissue regeneration
Primary goals of mucogingival surgery have changed with time from maintaining gingival health and prevent further progression of the recession to providing predictable root coverage solving patients' esthetic demands.
Many surgical techniques have been utilized to restore gingival tissue dimensions including the use of autologous soft tissue graft. Longitudinal studies have shown that procedures using pedicle and free grafts are both effective for this purpose. However, since this technique uses epithelialized grafts, it generally results in compromised aesthetics ("patch-like area"). Alternatively free connective tissue grafts (CTG) are used providing similar predictability but resulting in better colour matching. Unfortunately, both techniques are associated with significant patient morbidity due to the wound at the palatal donor site. To avoid patient morbidity, acellular dermal allografts have been used as substitutes for palatal donor tissue, demonstrating the possible and promising use of allograft material. However, since the allograft material is derived from human cadavers; it is associated with ethical concerns and the risk of disease transmission.
In patients with a residual amount of keratinized tissue, the coronally advanced flap (CAF) - first introduce by Norber et al. (1926) - has been demonstrated to be very effective in treatment of multiple and single recessions with advantages in terms of aesthetics and morbidity. Although CAF is a safe and predictable approach for root coverage, the application of this surgical technique in conjunction with autologous or synthetic material was reported to enhance the probability to achieve complete root coverage in Miller Class I and II gingival recessions. A promising option to avoid patient morbidity and the use of autologous transplants or allografts is the use of collagen matrices from porcine origin, such as Mucograft®. Similar devices have been extensively used for guided tissue regeneration procedures. Mucograft® provides an ideal matrix for blood vessel and soft tissue ingrowth, which is likely to improve the results and the predictability of recession coverage procedure using the CAF.
|Prof. Mariano Sanz|
|Madrid, Spain, 2804|
|Principal Investigator:||Mariano Sanz, Prof.||Department of Periodontology, University Complutense Madrid, Spain|
|Principal Investigator:||Soren Jepsen, Prof.||Department of Periodontology, University of Bonn, Germany|
|Principal Investigator:||Jan Wennström, Prof.||Department of Periodontology, University of Gothenburg, Sweden|
|Principal Investigator:||Giovanni Zucchelli, Prof.||Department of Periodontology, University of Bologna, Italy|
|Study Director:||Lorenz Uebersax, Dr.||Geistlich Pharma AG, Wolhusen, Switzerland|
|Principal Investigator:||Bernd Heinz, Dr||Private practice Hamburg, Germany|
|Principal Investigator:||Massimo DeSanctis, Prof.||Private Practice Firenze|