Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05988086 |
| Other study ID # |
R-OS-9-22-1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 10, 2022 |
| Est. completion date |
September 30, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Tanta University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
