The objective of this study is to compare the safety and efficacy of the bone tissue engineering kit-composed of 10⁶ mesenchymal stem cells derived from deciduous dental pulp combined with a collagen- and hydroxyapatite-based biomaterial-with secondary autogenous bone grafting for alveolar cleft closure in patients with cleft lip and palate.
Individuals aged 6 to 11 years with unilateral pre- and transforamen cleft lip and palate who have an indication for bone grafting will be included.
The study will be conducted in two stages. In Stage 1, patients will undergo surgery using only the bioengineering kit, and the primary outcome will be the average length of hospital stay after grafting with the engineering kit. In Stage 2, patients will be randomized to receive either the bioengineering kit treatment or the standard iliac crest bone graft surgery. In this stage, the primary outcome will be the success rate of the cleft lip and palate repair surgery, determined by the amount of bone formation in the alveolar cleft region, measured through volumetric analyses of computed tomography scans performed 12 months after grafting.
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;
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;
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 the cleft lip and palate repair surgery
average amount of bone formation in the alveolar cleft region, measured through volumetric analyses of computed tomography scans
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