NCT03766217

Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Hospital Sirio-Libanes · Academic / Other
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Accepted

Summary

Iliac crest autogenous bone graft is accepted as the most effective method for secondary alveolar cleft repair. However this method is associated with complications. As an alternative, mesenchymal stem cells associated with biomaterials have been used for the rehabilitation of the alveolar bone cleft of patients with cleft lip and palate. This is a RCT comparing mesenchymal stem cells obtained from autogenous deciduous dental pulp associated with biomaterials versus iliac crest autogenous bone graft for secondary alveolar cleft repair.

Conditions

• Cleft Lip and Palate

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Mesenchymal stem cells associated with biomaterials	Deciduous dental pulp mesenchymal stem cells associated with hydroxyapatita/collagen.
COMBINATION_PRODUCT	Iliac crest autogenous bone graft	Autogenous bone will be obtained from iliac crest.

Timeline

• Start date: 2019-04-05
• Primary completion: 2019-12-06
• Completion: 2019-12-15
• First posted: 2018-12-06
• Last updated: 2020-05-13

Locations

1 site across 1 country: Brazil