The Effect of Bone Marrow Stem Cells Harvested from the Iliac Crest Versus Mandibular Ramus in Alveolar Cleft Regeneration

Completed

• Conditions: Cleft Lip and Palate

• Registration Number: NCT06636643
• Lead Sponsor: Faculty of Dental Medicine for Girls

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

Study Timeline

• Study Start: 2021-04-15
• Primary Completion: 2021-05-20
• Study Completion: 2024-05-29
• Status Verified: 2024-10
• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-09
• Last Update Submitted: 2024-10-09
• Study First Posted: 2024-10-10
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The utilization of Mandibular Ramus-derived BMSCs presents a groundbreaking advancement in maxillofacial reconstruction. This approach offers numerous advantages, including reduced surgical complications	6 months	Based on the given data, there is a significant difference the volume reduction was significantly different between both groups being better in group A compared to group B (P=0.047). Whereas there was an insignificant difference between both groups regarding the preoperative and postoperative volume area.

Trial Locations

Locations (1)

Al azhar university; 🇪🇬 Cairo, Egypt