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

Fayoum University

Status: Completed

Conditions: Alveolar Cleft Grafting

Treatments: Procedure: bone marrow concentrate alveolar cleft grafting; Procedure: Autogenous alveolar grafting

Study type: Interventional

Funder types: Other

Identifiers

NCT04414423

BMC AlvCleft

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 18 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Bone marrow concentrate

Experimental group

Description:

Bone marrow concentrate combined with Autogenous bone graft

Treatment:

Procedure: bone marrow concentrate alveolar cleft grafting

autogenous bone graft

Active Comparator group

Description:

grafting with autogenous bone graft

Treatment:

Procedure: Autogenous alveolar grafting