Clinical Trial: The Use of Mucograft® to Treat Gingival Recession

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Clinical Applications of 3D Collagen Matrix (Mucograft®) in the Management of Gingival Recession: a Randomized Controlled Trial

Brief Summary:

Twenty patients with gingival recession will be enrolled in this trial. Gingival recession will be treated in one side by applying Mucograft® with coronally advanced flap (CAF) while on the opposite side a connective tissue graft (from the palate) will be applied with a CAF.

Patients will be followed for 3 and 6 months by measuring the clinical indexes and statistical analyses will be performed to compare the results and to assess the success of Mucograft®.


Detailed Summary: Many surgical techniques have used to treat gingival recession such aas repositioned flaps, autologous soft tissue grafts (connective tissue graft or free gingival grafts) or allografts like acellular dermal which can be used as substitutes for palatal donor tissue. Mucograft® (3D collagen matrix) is also an allograft from porcine origin and is designed for soft tissue regeneration and considered the ideal solution to autogenous soft tissue grafts and it provides an ideal matrix for blood vessel and soft tissue ingrowth.
Sponsor: Damascus University

Current Primary Outcome: Change in the Clinical Attachment Level Index [ Time Frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively ]

Clinical Attachment Level is dependent on measuring the pocket depth as well as the amount of gingival recession using specific tools. The measurement is going to be recorded in millimeters.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Probing Depth [ Time Frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively ]
    Probing depth is going to be measuring using a specific tool (UNC-15 probe).
  • Change in Gingival Recession [ Time Frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively ]
    Gingival recession is measured from the cemento-enamel junction to the gingival margin of the recessed tissues.
  • Change in Gingival Biotype [ Time Frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively ]
    Gingival biotype is assessed by an endodontic file which used to determine the thickness of the gingival tissues (i.e. thick or thin).
  • Change in Root Coverage Index [ Time Frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively ]
    The amount of root exposure will be measured and compared to the total length of the root
  • Change in Resistance to Muscular Pull [ Time Frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively ]
    The cheeks or lips are going to be retracted by hand or by a mirror in order to see the movement of the free gingival tissues. The movement will be esitmated in millimeters.
  • Change in Color Match Index [ Time Frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively ]
  • Shrinkage index at three months [ Time Frame: Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at three months exactly post-operatively. ]
  • Shrinkage index at six months [ Time Frame: Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at six months exactly post-operatively. ]


Original Secondary Outcome:

  • Change in Probing Depth [ Time Frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively ]
    Probing depth is going to be measuring using a specific tool (UNC-15 probe).
  • Change in Gingival Recession [ Time Frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively ]
    Gingival recession is measured from the cemento-enamel junction to the gingival margin of the recessed tissues.
  • Change in Gingival Biotype [ Time Frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively ]
    Gingival biotype is assessed by an endodontic file which used to determine the thickness of the gingival tissues (i.e. thick or thin).
  • Change in Root Coverage Index [ Time Frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively ]
    The amount of root exposure will be measured and compared to the total length of the root
  • Change in Resistance to Muscular Pull [ Time Frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively ]
  • Change in Color Match Index [ Time Frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively ]
  • Shrinkage index at three months [ Time Frame: Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at three months exactly post-operatively. ]
  • Shrinkage index at six months [ Time Frame: Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at six months exactly post-operatively. ]


Information By: Damascus University

Dates:
Date Received: November 29, 2016
Date Started: August 2016
Date Completion: December 2017
Last Updated: May 9, 2017
Last Verified: May 2017