Double Closure of Nasal Layer in Alveolar Cleft Grafting
Condition: Alveolar Cleft
Study type: Interventional

Summary: 
      The aim of this prospective study is to evaluate both clinically and radiologically the
      efficacy of using autologous platelets rich fibrin versus collagen membrane for nasal layer
      closure in secondary alveolar cleft repair.
    

Detailed description: 
      Patients and methods: Twenty-four patients with alveolar clefts will be included in this
      study. The patients will be evaluated with age ranging between (7 - 12) years. The patients
      will be received, clinically and radiologically examined, and managed at the Oral and
      Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.

      The selected children should possess the following criteria: Their permanent canines either
      not or partially erupted, has no systemic disorder which can affect the grafting outcome and
      healing process such as juvenile diabetes mellitus, kidney, liver, or blood diseases and has
      no associated craniofacial syndromes. The patients will be classified into two groups
      according to incorporation of autologous platelet rich fibrin or collagen membrane for nasal
      layer closure with the grafting material, as follow: Group 1: This will include 12 children
      in whom nasal layer of alveolar cleft will be repaired using autologous platelet rich fibrin
      with autogenous chin bone. Group 2: This will include 12 children in whom nasal layer of
      alveolar cleft will be repaired using collagen membrane with autogenous chin bone.

      Preoperative evaluation of alveolar cleft site:

      all patients will be examined clinically and radiologically. Clinical examination: This will
      consider the stability of maxillary segments, presence of old scar, asymmetry of the alar
      base, presence of oronasal fistula, and the presence of erupting teeth in the cleft.

      Radiological examination: Panoramic radiographs will be done for each patient and examined as
      regard: the morphology of the cleft area, the size of the cleft side, the presence or absence
      of permanent lateral incisor and canine, the development of root length, and stage of
      eruption of permanent canine and lateral incisor. In addition, Axial computed tomography (CT)
      scans will be done for each patient to assess and measure local bone mineral density of
      grafted alveolar bone cleft.

      Postoperative evaluation of the grafted site:

      The grafted site will be evaluated clinically for healing condition at the follow up periods
      (1st week, then 1st , 3rd ,6th ,and 9th month postoperatively) ; regarding the presence of
      inflammation or infection , the soft tissue scar overlying the bone graft , tenderness of
      bone graft site , recurrence of oronasal fistula , alveolar ridge contour in cleft region and
      eruption of cleft related teeth . Radiological evaluation will be done for each patient using
      Axial computed tomography (CT) scans at the follow up period (3rd and 9th month
      postoperatively) to assess and measure local bone mineral density.
    

Intervention name(s): platelet rich fibrin; collagen membrane
Intervention type(s): Procedure; Procedure
Intervention description(s): 12 children in whom nasal layer of alveolar cleft will be repaired using autologous platelet rich fibrin with autogenous chin bone.; 12 children in whom nasal layer of alveolar cleft will be repaired using collagen membrane with autogenous chin bone.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: alveolar cleft; collagen membrane; platelet rich fibrin