Safety and Efficacy of Bone Bioengineering Kit With Stem Cells for Alveolar Cleft Repair
NCT ID: NCT07305623
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
205 participants
INTERVENTIONAL
2026-07-31
2027-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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bioengineering kit
Patients will receive the bioengineering kit composed of stem cells from deciduous teeth and biomaterial.
Bioengineering kit composed of stem cells from deciduous teeth and biomaterial.
Bone 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
Standard iliac crest bone graft surgery
iliac crest bone graft surgery
standard iliac crest bone graft surgery
Interventions
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Bioengineering kit composed of stem cells from deciduous teeth and biomaterial.
Bone 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
standard iliac crest bone graft surgery
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Years
11 Years
ALL
No
Sponsors
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Instituto de Tecnologia do Paraná
OTHER
Responsible Party
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Daniela Franco Bueno
DDS, PhD
Locations
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Hospital Pequeno Príncipe
Curitiba, Paraná, Brazil
Countries
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Facility Contacts
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Gustavo Lara Achôa, DDS
Role: primary
Other Identifiers
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TECPAR_2025
Identifier Type: -
Identifier Source: org_study_id