Skip to main content
OpenTrials
Completed

NCT Number: NCT04414423

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alveolar Cleft Grafting

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Al Fayyum, Egypt

Loading trial locations.

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Syndromic cases will be excluded
  • Previous operated cases

Treatment and study plan

bone marrow concentrate alveolar cleft grafting

Procedure

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

Autogenous alveolar grafting

Procedure

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

Primary outcomes

  1. bone volume

    Time frame: 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 outcomes

  1. bone density

    Time frame: six months postoperative

    the average bone density will be measured from the CBCT

  2. bone formation ratio

    Time frame: six months postoperative

    BF% = (formed volume/alveolar defect) × 100%.

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2020
Registry last updated
Dec 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.