Double Closure of Nasal Layer in Alveolar Cleft Grafting

Evaluation of Using Platelet Rich Fibrin Versus Collagen Membrane for Enhancing Healing of Secondary Grafted Alveolar Cleft

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.

Study Overview

• Status: Completed
• Conditions: Alveolar Cleft
• Intervention / Treatment: Procedure: platelet rich fibrin; Procedure: collagen membrane

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 3111
    • Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: platelet rich fibrin; 12 children in whom nasal layer of alveolar cleft will be repaired using autologous platelet rich fibrin with autogenous chin bone.
Active Comparator: 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.	Procedure: collagen membrane; 12 children in whom nasal layer of alveolar cleft will be repaired using collagen membrane with autogenous chin bone.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone mineral density.	density of bone to measure (D1,D2,D3,D4) Frome 150HU to 1250HU	9 months

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: marwa t Ibrahim, lecturer, Tanta university

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Actual): March 10, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: collagen membrane; platelet rich fibrin; alveolar cleft
• Other Study ID Numbers: R-OS-9-22-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No