Tissue Engineered Constructs for Alveolar Cleft Repair

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03563495

Enrollment

Registered

2018-06-20

Start date

2015-02-28

Completion date

2017-09-30

Last updated

2018-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip and Palate

Keywords

tissue engineering., stem cells., autogenous grafts.

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.

Interventions

OTHERtissue engineered group

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

PROCEDUREautogenous bone graft group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

8 Years to 14 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026