Double Closure of Nasal Layer in Alveolar Cleft Grafting

Not Applicable

Completed

• Conditions: Alveolar Cleft
• Interventions: Procedure: platelet rich fibrin; Procedure: collagen membrane

• Registration Number: NCT05988086
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study Start: 2022-10-10
• Primary Completion: 2023-03-10
• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-08-04
• Study First Posted: 2023-08-14
• Study Completion: 2023-09-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: platelet rich fibrin	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.
Group 2:collagen membrane	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.

Primary Outcome Measures

Name	Time	Method
inflammation score scale	1 month	0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation
density of bone	1 month	density of bone to measure (D1,D2,D3,D4) Frome 150HU to 1250HU
visual analogue scale	1 month	0 representing no pain and 10 representing the highest level of pain

Secondary Outcome Measures

Name	Time	Method
bone mineral density.	9 months	density of bone to measure (D1,D2,D3,D4) Frome 150HU to 1250HU

Trial Locations

Locations (1)

Egypt; 🇪🇬 Tanta, Egypt