Clinical Trials Directory

Trials / Completed

CompletedNCT04414423

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

Combination of Bone Marrow Concentrate and Iliac Cancellous Bone Graft in Alveolar Cleft Grafting: a Clinical & Radiographic Evaluation

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
18 (actual)
Sponsor
Fayoum University · Academic / Other
Sex
All
Age
8 Years – 12 Years
Healthy volunteers
Not accepted

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%.

Conditions

Interventions

TypeNameDescription
PROCEDUREbone marrow concentrate alveolar cleft graftingpatients will undergo surgery to repair alveolar cleft with autogenous bone graft combined with bone marrow concentrate
PROCEDUREAutogenous alveolar graftingpatients will undergo surgery to repair alveolar cleft with autogenous bone graft

Timeline

Start date
2020-11-01
Primary completion
2021-11-20
Completion
2021-12-01
First posted
2020-06-04
Last updated
2021-12-07

Locations

2 sites across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04414423. Inclusion in this directory is not an endorsement.