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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04414423

Enrollment

Registered

2020-06-04

Start date

2020-11-01

Completion date

2021-12-01

Last updated

2021-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Cleft Grafting

Keywords

bone marrow concentrate, alveolar cleft, CBCT, Bone density, bone volume

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%.

Interventions

PROCEDUREbone marrow concentrate alveolar cleft grafting

patients will undergo surgery to repair alveolar cleft with autogenous bone graft combined with bone marrow concentrate

PROCEDUREAutogenous alveolar grafting

patients will undergo surgery to repair alveolar cleft with autogenous bone graft

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Intervention model description

Eighteen patients will be divided into two equal groups. Each group comprises nine patients.

Eligibility

Sex/Gender

ALL

Age

8 Years to 12 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Syndromic cases will be excluded * Previous operated cases

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026