A Randomized Controlled Clinical Trial to Evaluate Safety and Effectiveness of CAF + Mucograft® Compared to CAF Alone in Patients With Gingival Recessions
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): Mucograft; Coronally advanced flap (CAF)
Intervention type(s): Device; Procedure
Intervention description(s): Collagen Matrix for soft tissue regeneration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: root coverage; gingival recession; keratinized gingiva