Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair
- Conditions
- Cleft Lip and Palate
- Interventions
- Combination Product: Iliac crest autogenous bone graftCombination Product: Mesenchymal stem cells associated with biomaterials
- Registration Number
- NCT03766217
- Lead Sponsor
- Hospital Sirio-Libanes
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- non syndromic unilateral cleft lip and palate;
- age between 7 and 12 years;
- to have the jaw aligned and ready to receive the graft.
- previous surgery to correct the alveolar cleft;
- have the canine erupted before grafting;
- incomplete orthodontic treatment;
- incomplete CT scan documentation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iliac crest autogenous bone graft Iliac crest autogenous bone graft 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. Mesenchymal stem cells associated with biomaterials Mesenchymal stem cells associated with biomaterials 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).
- Primary Outcome Measures
Name Time Method Alveolar bone filling rate 12 months Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area.
Serious adverse events 12 months 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.
- Secondary Outcome Measures
Name Time Method Non serious adverse events 15 days; 3, 6 and 12 months Frequency of participants experiencing at least one non serious adverse event
Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair Bone tissue engineering Alveolar bone filling rate 6 months Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area.
Patient-reported outcome (PRO, including appearance, fuction and quality of life) pre surgery and 12 months 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)
Position of the canine tooth and formation of dental root 12 months Position of the canine tooth and formation of dental root assessed by CT scan
Serious adverse events 15 days; 3 and 6 months 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.
Trial Locations
- Locations (1)
Hospital Sírio-Libanes
🇧🇷São Paulo, Brazil