Non syndromic unilateral cleft lip and palate
Conditions
Interventions
Group (1)
Mesenchymal stem cells graft associated with biomaterials.
Mesenchymal stem cells obtained from autogenous deciduous dental pulp is associated with hydroxyatite and collagen. The stem cells
Biological/vaccine
Sponsors
Hospital Municipal Infantil Menino Jesus
Hospital Sírio-Libanês
Eligibility
Age
8 Years to No maximum
Inclusion criteria
Inclusion criteria: 20 patients with unilateral alveolar cleft defects, aged 8 to 12 years, were selected at the Cleft Lip and Palate Unit of the Hospital Municipal Infantil Menino Jesus. All patients underwent preoperative orthodontic expansion of maxillary segments.
Exclusion criteria
Exclusion criteria: Previous alveolar surgery, previous eruption of the canine or incomplete records.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EXPECTED OUTCOME 1 Alveolar bone filling* - Definition: percentage of filled area of fissure that was filled by the graft compared to the area in the preoperative alveolar fissure. - Method for evaluation: assessed by CT. - Time-point: pre-operative and 6 and 12 months post-intervention. - Type of variable: dichotomous * main primary outcome ;EXPECTED OUTCOME 2 Severe adverse events. - Definition: Severe adverse events are defined as those that bring threat to life, hospitalization, disability, fetal loss / abortion, malformation and death. - Method used to evaluate: percentage of patients with at least one severe adverse event according to observation of the surgeon, patients, family members or caregivers. - Time-point: 7 and 15 days post-intervention. - Type of variable: dichotomous | — |
Secondary
| Measure | Time frame |
|---|---|
| EXPECTED OUTCOME 3 Non serious adverse events - Definition: Non serious adverse events - Method used to evaluate: percentage of patients with at least one non serious adverse event according to observation of the surgeon, patients, family members or caregivers. - Time-point: 7 and 15 days post-intervention. - Type of variable: dichotomous ;EXPECTED OUTCOME 4 Canine position and root formation - Definition: percentage of patients with root formation of the canine tooth. Root formation is considered present when at least 2/3 of the root is formed. - Method used to evaluate: periapical radiography - Time-point: pre-intervention and 12 months after the intervention. - Type of variable: dichotomous;EXPECTED OUTCOME 5 Consumption of pain medications in the postoperative period - Definition: consumption of analgesic drugs (mg / kg body weight). - Method used to evaluate: data collected from the patient's register. - Time-point: intraoperative and postoperative (up to hospital discharge) - Type of variable: continuous (mean) | — |
Countries
Brazil
Contacts
Public ContactDaniela Bueno
Hospital Sírio-Libanês
Outcome results
None listed