Combination of Bone Marrow Concentrate and Iliac Cancellous Bone Graft in Alveolar Cleft Grafting

Not Applicable

Completed

• Conditions: Alveolar Cleft Grafting
• Interventions: Procedure: bone marrow concentrate alveolar cleft grafting; Procedure: Autogenous alveolar grafting

• Registration Number: NCT04414423
• Lead Sponsor: Fayoum University

Brief Summary

The aim of this study will be to analyze the newly formed bone volume and density, 6 months after alveolar cleft grafting using iliac cancellous bone graft, with and without bone marrow concentrate.

Detailed Description

Twelve patients with unilateral alveolar cleft will be enrolled in this randomized comparative study.

The patients will be divided into two groups, the control (group A) who received illiac cancellous bone graft and study group who received a combination of bone marrow concentrate and illiac cancellous bone graft (group B).

Cone Beam CT (CBCT) images will be done prior to surgery to asses preoperative alveolar defect volume. Six months postoperative CBCT images will be done and postoperative newly bone formed volume and density will be evaluated and bone formation ratio (BF%) will be calculated as follows: BF% = (formed volume/alveolar defect) × 100%.

Study Timeline

• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-05-29
• Study First Posted: 2020-06-04
• Study Start: 2020-11-01
• Primary Completion: 2021-11-20
• Status Verified: 2021-12
• Study Completion: 2021-12-01
• Last Update Submitted: 2021-12-05
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Patients suffering from maxillary alveolar cleft
• Patient with Primary, complete cleft lip

Exclusion Criteria

• Syndromic cases will be excluded
• Previous operated cases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bone marrow concentrate	bone marrow concentrate alveolar cleft grafting	Bone marrow concentrate combined with Autogenous bone graft
autogenous bone graft	Autogenous alveolar grafting	grafting with autogenous bone graft

Primary Outcome Measures

Name	Time	Method
bone volume	six months postoperative	V= (A1xT) + ( A2 xT) + .......+ (An xT) where: V= volume A= area T= thickness of the axial C.T slice N=number of slices

Secondary Outcome Measures

Name	Time	Method
bone formation ratio	six months postoperative	BF% = (formed volume/alveolar defect) × 100%.
bone density	six months postoperative	the average bone density will be measured from the CBCT

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Fayoum, Egypt