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

NCT06636643 | Completed

• 1 other identifier: Al azhar university
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Lip and Palate

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Faculty of Dental Medicine for Girls: lead

Study Sites (1)

Al azhar university

Cairo, Egypt

Location

Related Links

• Related Info

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doaa selim

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 10, 2024
• Study Start: April 15, 2021
• Primary Completion: May 20, 2021
• Study Completion: May 29, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-10

Locations

EG (1)