The objective of this study is to compare the safety and efficacy of a bone tissue engineering kit - composed of 10⁶ autologous mesenchymal stem cells derived from deciduous dental pulp combined with Bio-Oss® Collagen - with secondary autogenous iliac crest bone grafting for alveolar cleft reconstruction in patients with cleft lip and palate.
Individuals aged 7 to 12 years with unilateral pre-foramen or transforamen cleft lip and palate who require secondary alveolar bone grafting and have previously cryopreserved autologous deciduous dental pulp-derived mesenchymal stem cells will be eligible for inclusion.
The study will be conducted in two stages. Stage 1 is a prospective, single-arm study designed to evaluate the initial safety of the investigational product, with primary endpoints consisting of the incidence of procedure-related adverse events and postoperative pain until hospital discharge. Stage 2 is a prospective, randomized, assessor-blinded clinical trial comparing the bone tissue engineering kit with standard autogenous iliac crest bone grafting. The co-primary endpoints are the success rate of alveolar reconstruction, defined as ≥70% bone fill of the alveolar cleft measured by volumetric computed tomography 12 months after surgery, and the incidence of procedure-related adverse events.
Written Informed Consent Form (ICF) signed by the participant's legally authorized representative.
Written Assent Form signed by the participant.
Patients aged 7 to 12 years at the time of secondary alveolar bone graft surgery.
Patients diagnosed with unilateral pre-foramen or transforamen cleft lip and palate.
Previous surgery for alveolar cleft repair.
Known allergy to latex gloves or suture materials (Catgut, Vicryl, Monocryl, Nylon, Polyester, or Polypropylene).
Uncontrolled systemic diseases or other clinical conditions that may increase surgical risk or interfere with bone healing, including, but not limited to, uncontrolled diabetes mellitus, clinically significant cardiovascular disease, or other conditions deemed relevant by the investigator.
Metabolic bone diseases or other conditions that may impair bone formation or healing.
Parallel
Bioengineering kit composed of stem cells from deciduous teeth and biomaterial.
Combination productBone tissue engineering kit composed of 10⁶ mesenchymal stromal cells/mesenchymal stem cells (MSCs) derived from dental pulp, combined with a biomaterial consisting of hydroxyapatite and collagen (BioOss Collagen, 250 mg, Geistlich).
iliac crest bone graft surgery
Procedure/Surgerystandard iliac crest bone graft surgery
Success rate of cleft lip and palate alveolar reconstruction surgery
Proportion of participants achieving successful alveolar reconstruction, defined as ≥70% filling of the alveolar cleft with newly formed bone, assessed by volumetric analysis of computed tomography scans.
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