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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
62
Deciduous dental pulp mesenchymal stem cells associated with hydroxyapatita/collagen.
Autogenous bone will be obtained from iliac crest.
Hospital Sírio-Libanes
São Paulo, Brazil
Alveolar bone filling rate
Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area.
Time frame: 12 months
Serious adverse events
Serious adverse events resulting in death, life-threatening event, hospitalization, prolongation of existing hospitalization (for \> 24 hours), persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. Important medical event that may not result in death, be life threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon medical judgment, it may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Frequency of participants experiencing at least one serious adverse event.
Time frame: 12 months
Non serious adverse events
Frequency of participants experiencing at least one non serious adverse event
Time frame: 15 days; 3, 6 and 12 months
Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair
Time frame: Bone tissue engineering
Position of the canine tooth and formation of dental root
Position of the canine tooth and formation of dental root assessed by CT scan
Time frame: 12 months
Alveolar bone filling rate
Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area.
Time frame: 6 months
Serious adverse events
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Serious adverse events resulting in death, life-threatening event, hospitalization, prolongation of existing hospitalization (for \> 24 hours), persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. Important medical event that may not result in death, be life threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon medical judgment, it may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Frequency of participants experiencing at least one serious adverse event.
Time frame: 15 days; 3 and 6 months
Patient-reported outcome (PRO, including appearance, fuction and quality of life)
Assessed by CLEFT-Q, a self-report PRO instrument, tool answered independently patients themselves, without interpretation by the parent(s) or healthcare provider. The CLEFT-Q consists of 13 independently functioning domains (171 items) measuring appearance, facial function and quality of life. Each domain is composed of a series of items that together evaluate a unidimensional construct. A higher score means a better result (continuous outcome, measured by: mean)
Time frame: pre surgery and 12 months