Safety and Efficacy of Bone Bioengineering Kit With Stem Cells for Alveolar Cleft Repair

Inclusion Criteria: * Signed Informed Consent Form (ICF) from the legal guardian; * Signed Assent Form from the participant; * Patients aged 6 to 11 years at the time of the secondary bone graft surgery; * Participants diagnosed with unilateral cleft lip and palate of the pre-foramen incisive or transforamen type; * Patients must have had mesenchymal stem cells derived from deciduous teeth collected and stored in a biobank prior to signing the Informed Consent Form (ICF); * Patients with the maxilla previously aligned through orthodontic treatment and deemed suitable for the alveolar bone graft procedure; * Patients who are reliable and willing to be available throughout the study, attend all required study visits, and are willing and able to comply with study procedures as necessary. Exclusion Criteria: * Previous surgery for alveolar cleft repair; * Presence of comorbidities (diabetes, cardiac conditions, hypertension) or allergies to latex gloves and suture materials (Catgut, Vicryl, Monocryl, Nylon, Polyester, or Polypropylene); * Presence of palatal fistulas resulting from previous surgeries; * Incomplete orthodontic or tomography documentation; * Eruption of the permanent canine prior to signing the Informed Consent Form (ICF) and Assent Form (AF), and prior to undergoing the secondary alveolar bone graft surgery; * Participants who are pregnant or breastfeeding at the time of screening or during the study.