Cleft Lip and Palate
Conditions
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.
Interventions
COMBINATION_PRODUCTMesenchymal stem cells associated with biomaterials
Deciduous dental pulp mesenchymal stem cells associated with hydroxyapatita/collagen.
COMBINATION_PRODUCTIliac crest autogenous bone graft
Autogenous bone will be obtained from iliac crest.
Sponsors
Ministry of Health, Brazil
Hospital Sirio-Libanes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Alveolar bone filling rate | 6 months | Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area. |
| Non serious adverse events | 15 days; 3, 6 and 12 months | Frequency of participants experiencing at least one non serious adverse event |
| 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) |
| 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. |
| Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair | Bone tissue engineering | — |
Countries
Brazil
Outcome results
None listed