Status:
COMPLETED
Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair
Lead Sponsor:
Hospital Sirio-Libanes
Collaborating Sponsors:
Ministry of Health, Brazil
Conditions:
Cleft Lip and Palate
Eligibility:
All Genders
7-12 years
Phase:
PHASE3
Brief 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 ste...
Eligibility Criteria
Inclusion
- non syndromic unilateral cleft lip and palate;
- age between 7 and 12 years;
- to have the jaw aligned and ready to receive the graft.
Exclusion
- previous surgery to correct the alveolar cleft;
- have the canine erupted before grafting;
- incomplete orthodontic treatment;
- incomplete CT scan documentation.
Key Trial Info
Start Date :
April 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2019
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03766217
Start Date
April 5 2019
End Date
December 15 2019
Last Update
May 13 2020
Active Locations (1)
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1
Hospital Sírio-Libanes
São Paulo, Brazil, 01308-050