Connective Tissue Graft Versus Mucograft Collagen Matrix for Coverage of Multiple Gingival Recession Defects
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional
Phase: Phase 4

Summary: 
      This study deals with coverage of multiple denuded roots. The current standard treatment
      requires surgical correction and uses soft tissue taken from the roof of the mouth to enhance
      results. The hypothesis of this trial is that a synthetic collagen matrix (called Mucograft)
      can be used to replace soft tissue taken from the subject. If the collagen matrix will prove
      to be equally as effective as the patient own tissue, it will be possible to avoid a more
      extensive surgery and decrease pain and discomfort.
    

Detailed description: 
      Objectives The main objective of this study is to assess if the Mucograft Collagen Matrix
      reduces morbidity, shortens time to recovery and improves patient based outcomes with respect
      to the use of autologous connective tissue graft harvested from the patient own palate when
      used to obtain root coverage of multiple adjacent gingival recessions.

      The secondary objective is to assess the non-inferiority - in terms of complete root
      coverage, percentage of root coverage and professional evaluation of aesthetics - of the use
      of Mucograft Collagen Matrix and autologous connective tissue harvested from the patient's
      own palate.

      Design and Outcomes This will be a parallel group, standard of care-controlled,
      assessor-blind, randomized, multicenter, multinational, clinical trial.

      The statistical design will be a superiority trial in terms of the primary outcomes (patient
      based outcomes) and non-inferiority trial in terms of the professional outcomes measuring
      root coverage and aesthetics.

      Sample size has been estimated in 140 subjects per treatment arm using a pilot case series
      analyzed with a multilevel statistical approach and a non inferiority margin of 0.25 mm in
      recession coverage.

      Randomization will be performed by computer generated random codes, using random permuted
      blocks with a block size of 4 to avoid uneven splits and minimization for the key prognostic
      factor cigarette smoking. Allocation will be concealed to the surgeons until completion of
      preparation of the recipient bed by opaque envelopes. A central study registrar will perform
      patient registration.

      Study locations will include academic centers and a practice-based research network in Italy,
      Switzerland, Germany, Belgium, France, Spain and Greece.

      A single examiner, blind with respect to the treatment assignment, will perform all
      measurements at each center. Trained personnel not involved with the surgical intervention
      will: i) administer patient questionnaires, ii) provide instructions and collect patient
      diaries. A single calibrated investigator with specific experience in using the specific
      score will centrally perform assessment of esthetic scores on standardized digital images.

      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 multiple recessions. Surgery will be standardized and the same
      procedures/materials will be employed to ensure consistency.

      Follow-up of individual patients will be 6 months (to be extended to 3 years if funding will
      be available)
    

Intervention name(s): Autologous connective tissue graft with rotated papilla flap; Collagen matrix construct (Mucograft)
Intervention type(s): Procedure; Device
Intervention description(s): Subepithelial connective tissue graft harvested from hard palate; Mucograft Collagen Matrix combined with rotated papilla flap
Other intervention name(s): Subepithelial connective tissue graft; Mucograft gingival augmentation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: gingival recession; root coverage; periodontal surgery; collagen matrix; mucograft; multiple exposed teeth