Tissue Engineered Constructs for Alveolar Cleft Repair

NCT03563495 | Completed

• 1 other identifier: MSCs in alveolar cleft repair
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cleft Lip and Palate

Keywords

tissue engineering.; stem cells.; autogenous grafts.

Outcome Measures

Primary Outcomes (1)

• Assessment of changes in the bone volume at the grafted alveolar cleft site from the immediate postoperative to 6 months

  Measuring the bone volume on CT scan

  Immediate postoperative and after 6 months

Secondary Outcomes (1)

• 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

Study Arms (2)

tissue engineered group

ACTIVE COMPARATOR

autogenous bone marrow derived and cultured stem cells loaded on collagen matrix was implanted in the alveolar cleft in the study group (1st arm)

Other: tissue engineered group

autogenous bone graft group

ACTIVE COMPARATOR

autogenous cortico-cancellous bone graft harvested from the anterior iliac crest was implanted in the alveolar cleft of the control group (2nd arm)

Procedure: autogenous bone graft group

Interventions

tissue engineered group OTHER

cultured and bone marrow derived autologous mesenchymal stem cells, loaded on collagen matrix (Osteovit)

Also known as: BM-MSCs on collagen matrix (Osteovit)

tissue engineered group

autogenous bone graft group PROCEDURE

autogenous bone graft group

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Cleft Lip

Interventions

osteovit

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator at Oral & Maxillofacial Surgery department, Faculty of Dentistry, Cairo University

Study Record Dates

• First Submitted: May 26, 2018
• First Posted: June 20, 2018
• Study Start: February 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 20, 2018

Record last verified: 2018-06