Xenogeneic Collagen Matrix or Palatal Connective Tissue Graft With a Coronally Advanced Flap in Class III Recessions
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      The purpose of this multi-center study is to compare the effectiveness of Mucograft versus
      connective tissue graft in combination with coronal advanced flap for the treatment of Miller
      class III recessions The connective tissue graft in combination with coronal advanced flap is
      considered the gold standard for the treatment of gingival recession in terms of percentage
      of root coverage and complete root coverage. However connective tissue graft harvesting from
      the palatal mucosa is often associated with increased patient morbidity, prolonged surgical
      time and is limited supply. To overcome these inconvenients many efforts are made to develop
      new materials (healing modifiers, barrier membranes and grafts substitutes) Recently a new
      two-layer , xenogenic collagen matrix (Mucograft: Geistlich Pharma , Wolhusen Switzerland)
      has been proposed for regenerative therapy involving teeth and implants. The use of this
      porcine collagen matrix has obtained promising results for treatment of Miller class I and II
      recession defects (isolated and multiple recession defects) The mayority of root coverage
      studies in the literature treats Miller class I and II recession defects .Surgical treatment
      of class III recesión defects is more challenging due to loss of interproximal bone and soft
      tissues and complete root coverage may not be expected . But some recent studies demonstrate
      complete root coverage and high percentage of root coverage in class III recessions. Also a
      new classification system using the level of interproximal attachment level has been proposed
      to predict the final root coverage outcome.

      So ,the soft tissue substitutes should be used also in Miller class III recession, and
      because of that fact, the investigators are conducting this study, to evaluate the
      effectiveness of Mucograft in Miller class III recessions compared with connective tissue
      graft.
    

Detailed description: 
      Given data reported by the study of Aroca in 2013 ,using the percentage of root coverage as a
      primary response variable the sample size was estimated in 20 patients. In addition, taking
      into account possible drop-outs, the investigators would increase the number of patients by
      20%, finally recruiting 24 patients per group.

      Randomization was performed by computer generated random codes Study locations will include
      two private centers in Spain. A single calibrated examiner, blind with respect to the
      treatment assignment, will perform all measurements at all center.

      A biostatistician blind with respect to treatment assignment will perform the analysis.

      Interventions and Duration The two intervention groups will consist of surgery with
      connective tissue graft (standard of care control) and surgery with the application of
      Mucograft Collagen Matrix (MCM, Test group). Experienced clinicians will deliver treatment
      consisting of root coverage surgery using coronally advanced flaps, the most utilized
      procedure for coverage of recessions. Surgery will be standardized and the same
      procedures/materials will be employed to ensure consistency.

      Follow-up of individual patients will be 12 months.
    

Intervention name(s): experimental: collagen matrix; Active Comparator: autologous connective tissue graft
Intervention type(s): Device; Other
Intervention description(s): Mucograft collagen matrix combined with coronal advanced flap; Soft tissue harvesting from patient palate with coronal advanced flap
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: split mouth
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gingival recession; Collagen matrix; Connective tissue graft; Coronally advanced flap; Root coverage; keratinized tissue; Periodontal disease