Clinical trial NCT06636643: The Effect of Bone Marrow Stem Cells Harvested from the Iliac Crest Versus Mandibular Ramus in Alveolar Cleft Regeneration
Official title: The Effect of Bone Marrow Stem Cells Harvested from the Iliac Crest Versus Mandibular Ramus in Alveolar Cleft Regeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cleft Lip and Palate
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2024-10-10
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with alveolar cleft defects randomly divided into two equal groups: Group A: received Autologous Bone Marrow Mesenchymal Stem Cells (BMMSCs) harvested from the mandibular ramus and seeded on a collagen sponge in combination with nanohydroxyapatite. Group B: received Autologous Bone Marrow Mesenchymal Stem Cells (BMMSCs) harvested from the lilac crest and seeded on a collagen sponge in combination with nanohydroxyapatite

Brief summary: This comparative and prospective study was conducted on 10 patients with alveolar cleft defects. Patients with alveolar cleft defects were randomly selected and randomly divided into two equal groups: Group A: received Autologous (BMMSCs) harvested from the mandibular ramus and seeded on a collagen sponge in combination with nanohydroxyapatite. Group B: received Autologous (BMMSCs) harvested from the lilac crest and seeded on a collagen sponge in combination with nanohydroxyapatite.

Detailed description: The utilization of Mandibular Ramus-derived BMSCs presents a groundbreaking advancement in maxillofacial reconstruction. This approach offers numerous advantages, including reduced surgical complications, improved precision and localization, higher osteogenic potential, and lower risks of graft rejection. Moreover, the combination of BMMNCs, nanohydroxyapatite, and PRF extracted from the mandible proves to be a viable alternative to traditional iliac crest grafting, promoting effective bone regeneration in alveolar cleft defects. By adopting this novel technique and harvesting site, It can can optimize surgical interventions, paving the way for enhanced standards of care and improving the quality of life for patients with maxillofacial challenges

Eligibility criteria: Inclusion Criteria:

* patient aged 8-15 years, not received any surgery for alveolar cleft defect, non-syndromic unilateral alveolar cleft with or without cleft palate, good oral hygiene and good compliance with the plaque-control instructions, medically fit for major surgical oral procedure.

Exclusion Criteria:

* pre-existing infection at the cleft site, patients with systemic diseases may affect bone healing.

Primary outcomes:
measure: The utilization of Mandibular Ramus-derived BMSCs presents a groundbreaking advancement in maxillofacial reconstruction. This approach offers numerous advantages, including reduced surgical complications
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al azhar university
Study officials:
References: