Clinical trial NCT05988086: Double Closure of Nasal Layer in Alveolar Cleft Grafting
Official title: Evaluation of Using Platelet Rich Fibrin Versus Collagen Membrane for Enhancing Healing of Secondary Grafted Alveolar Cleft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Cleft
Keywords: alveolar cleft
collagen membrane
platelet rich fibrin
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 24
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. patients with unilateral alveolar cleft
2. the patient's permenant canines either not or partially erupted
3. medically free patients

Exclusion Criteria:

1. patients with bilateral alveolar cleft
2. medically compromised patients
3. Any associated craniofacial syndromes.

Primary outcomes:
measure: visual analogue scale
timeFrame: 1 month
measure: inflammation score scale
timeFrame: 1 month
measure: density of bone
timeFrame: 1 month
Secondary outcomes:
measure: bone mineral density.
timeFrame: 9 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Egypt
Study officials:
affiliation: Tanta University
name: Marwa T Ibrahim, lecturer
role: PRINCIPAL_INVESTIGATOR
References: