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

December 5, 2021 updated by: Alshaimaa Ahmed shabaan, Fayoum University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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%.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 21523
        • Faculty of Dentistry
      • Fayoum, Egypt, 63514
        • Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Syndromic cases will be excluded
  • Previous operated cases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bone marrow concentrate
Bone marrow concentrate combined with Autogenous bone graft
Procedure: bone marrow concentrate alveolar cleft grafting
patients will undergo surgery to repair alveolar cleft with autogenous bone graft combined with bone marrow concentrate
ACTIVE_COMPARATOR: autogenous bone graft
grafting with autogenous bone graft
Procedure: Autogenous alveolar grafting
patients will undergo surgery to repair alveolar cleft with autogenous bone graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
six months postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2020

Primary Completion (ACTUAL)

November 20, 2021

Study Completion (ACTUAL)

December 1, 2021

Study Registration Dates

First Submitted

May 25, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (ACTUAL)

June 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 7, 2021

Last Update Submitted That Met QC Criteria

December 5, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BMC AlvCleft

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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