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

NCT03766217 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2020-05-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • Hospital Sirio-Libanes

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-05
Primary Completion
2019-12-06
Completion
2019-12-15

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03766217 on ClinicalTrials.gov