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

F

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

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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