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

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.

Study Overview

• Status: Completed
• Conditions: Cleft Lip and Palate

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 Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Al Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
received Autologous (BMMSCs) harvested from the mandibular ramus and seeded on a collagen sponge in; received Autologous (BMMSCs) harvested from the lilac crest and seeded on a collagen sponge in combination with nanohydroxyapatite.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The utilization of Mandibular Ramus-derived BMSCs presents a groundbreaking advancement in maxillofacial reconstruction. This approach offers numerous advantages, including reduced surgical complications	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.	6 months

Collaborators and Investigators

• Sponsor: Faculty of Dental Medicine for Girls

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Actual): May 20, 2021
• Study Completion (Actual): May 29, 2024

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: Al azhar university

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not yet decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No