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OpenTrials
Completed

NCT Number: NCT03563495

Tissue Engineered Constructs for Alveolar Cleft Repair

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.

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Key information

Conditions

Cleft Lip and Palate Cleft Lip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Lip Diseases Mouth Abnormalities Mouth Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

tissue engineered group

Other

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

Other names: BM-MSCs on collagen matrix (Osteovit)

autogenous bone graft group

Procedure

Primary outcomes

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

    Time frame: Immediate postoperative and after 6 months

    Measuring the bone volume on CT scan

Secondary outcomes

  1. Assessment of changes in the bone density at the grafted alveolar cleft site from the immediate postoperative to 6 months

    Time frame: Immediate postoperative and after 6 months

    Measuring the bone density on CT scan

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical, Volumetric and Densitometric Evaluation of Tissue Engineered (TE) Constructs for Secondary Alveolar Cleft Reconstruction (Short Term Randomized Controlled Clinical Trial)

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 20, 2018
Registry last updated
Jun 20, 2018

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.

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