Evaluation of Using Platelet Rich Fibrin Versus Collagen Membrane for Enhancing Healing of Secondary Grafted Alveolar Cleft
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- inflammation score scale
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 7 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •patients with unilateral alveolar cleft
- •the patient's permenant canines either not or partially erupted
- •medically free patients
Exclusion Criteria
- •patients with bilateral alveolar cleft
- •medically compromised patients
- •Any associated craniofacial syndromes.
Arms & Interventions
Group 2:collagen membrane
Group 2: This will include 12 children in whom nasal layer of alveolar cleft will be repaired using collagen membrane with autogenous chin bone.
Intervention: collagen membrane (Procedure)
Group 1: platelet rich fibrin
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.
Intervention: platelet rich fibrin (Procedure)
Outcomes
Primary Outcomes
inflammation score scale
Time Frame: 1 month
0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation
density of bone
Time Frame: 1 month
density of bone to measure (D1,D2,D3,D4) Frome 150HU to 1250HU
visual analogue scale
Time Frame: 1 month
0 representing no pain and 10 representing the highest level of pain
Secondary Outcomes
- bone mineral density.(9 months)
Investigators
Marwa Taha Ibrahim
lecturer
Tanta University