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

Hospital Sirio-Libanes

Status and phase: Completed; Phase 3

Conditions: Cleft Lip and Palate

Treatments: Combination Product: Iliac crest autogenous bone graft; Combination Product: Mesenchymal stem cells associated with biomaterials

Study type: Interventional

Funder types: Other

Identifiers

NCT03766217

CAAE47719215.5.0000.5461

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 7 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• previous surgery to correct the alveolar cleft;
• have the canine erupted before grafting;
• incomplete orthodontic treatment;
• incomplete CT scan documentation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Mesenchymal stem cells associated with biomaterials

Experimental group

Description:

Mesenchymal stem cells obtained from autogenous deciduous dental pulp associated with biomaterials. The stem cells will be obtained by enzimatic digestion in GMP laboratory and will be seed into the biomaterial (hydroxyapatite/collagen).

Treatment:

Combination Product: Mesenchymal stem cells associated with biomaterials

Iliac crest autogenous bone graft

Active Comparator group

Description:

Autogenous bone will be obtained from iliac crest. The prepare of the receptor area will be the same in both arms and will follow current recommendations.

Treatment:

Combination Product: Iliac crest autogenous bone graft