Tissue Engineered Constructs for Alveolar Cleft Repair

Not Applicable

Completed

• Conditions: Cleft Lip and Palate
• Interventions: Procedure: autogenous bone graft group; Other: tissue engineered group

• Registration Number: NCT03563495
• Lead Sponsor: Cairo University

Brief Summary

Description of the research question

In children undergoing unilateral alveolar cleft reconstruction, would stem cells carried on collagen scaffold provide bone of a good quality and quantity if compared to autogenous bone grafting?

Objective of the study:

• Research hypothesis

The tissue engineered constructs will provide sufficient bone of a good quality and quantity if compared to autogenous bone graft in children undergoing unilateral alveolar cleft reconstruction.

* The objectives

The primary objective:

Assessment of bone volume (quantity) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.

The secondary objective:

Assessment of bone density (quality) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2017-07
• Study Completion: 2017-09
• Study First Submitted: 2018-05-26
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-19
• Last Update Submitted: 2018-06-19
• Study First Posted: 2018-06-20
• Last Update Posted: 2018-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Children with maxillary unilateral alveolar clefts requiring reconstruction
• Children free from any systemic disease that may affect normal healing of bone
• Children in an age range (8-14) year.

Exclusion criteria

• Bilateral alveolar clefts.
• Cleft lip or palate not including the alveolus.
• Immunocompromized patients.
• Children who undergone previous bone grafting procedure for the alveolar cleft

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
autogenous bone graft group	autogenous bone graft group	autogenous cortico-cancellous bone graft harvested from the anterior iliac crest was implanted in the alveolar cleft of the control group (2nd arm)
tissue engineered group	tissue engineered group	autogenous bone marrow derived and cultured stem cells loaded on collagen matrix was implanted in the alveolar cleft in the study group (1st arm)

Primary Outcome Measures

Name	Time	Method
Assessment of changes in the bone volume at the grafted alveolar cleft site from the immediate postoperative to 6 months	Immediate postoperative and after 6 months	Measuring the bone volume on CT scan

Secondary Outcome Measures

Name	Time	Method
Assessment of changes in the bone density at the grafted alveolar cleft site from the immediate postoperative to 6 months	Immediate postoperative and after 6 months	Measuring the bone density on CT scan