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OpenTrials
Completed

NCT Number: NCT06636643

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.

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Key information

Conditions

Cleft Lip and Palate Cleft Lip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Lip Diseases Mouth Abnormalities Mouth Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Sex eligibility

All sexes

Study type

Observational

Primary location

Al azhar university

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Faculty of Dental Medicine for Girls

Other Gov

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2024
First posted
Oct 10, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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