Double Closure of Nasal Layer in Alveolar Cleft Grafting
NCT ID: NCT05988086
Last Updated: 2023-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2022-10-10
2023-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
platelet rich fibrin
12 children in whom nasal layer of alveolar cleft will be repaired using autologous platelet rich fibrin with autogenous chin bone.
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.
collagen membrane
12 children in whom nasal layer of alveolar cleft will be repaired using collagen membrane with autogenous chin bone.
Interventions
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platelet rich fibrin
12 children in whom nasal layer of alveolar cleft will be repaired using autologous platelet rich fibrin with autogenous chin bone.
collagen membrane
12 children in whom nasal layer of alveolar cleft will be repaired using collagen membrane with autogenous chin bone.
Eligibility Criteria
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Inclusion Criteria
2. the patient's permenant canines either not or partially erupted
3. medically free patients
Exclusion Criteria
2. medically compromised patients
3. Any associated craniofacial syndromes.
7 Years
12 Years
ALL
Yes
Sponsors
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Tanta University
OTHER
Responsible Party
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Marwa Taha Ibrahim
lecturer
Principal Investigators
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Marwa T Ibrahim, lecturer
Role: PRINCIPAL_INVESTIGATOR
Tanta University
Locations
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Egypt
Tanta, , Egypt
Countries
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Other Identifiers
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R-OS-9-22-1
Identifier Type: -
Identifier Source: org_study_id