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Phase 4
Age: 6Years - 15Years
All Genders
ID04234971

Evaluating Cost Effectiveness of Bone Graft Methods in Children with Cleft Lip and Palate Undergoing Alveolar Bone Grafting

Led by The University of Texas Health Science Center, Houston · Updated on 2026-02-19

40

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the cost effectiveness of using Bone Morphogenic Protein BMP combined with Demineralized Bone Matrix DBM compared to the traditional autologous Iliac Crest Bone Graft ICBG in patients with Cleft Lip and Palate CLP undergoing alveolar bone graft ABG surgery. This trial aims to see if BMPDBM reduces post-operative pain, shortens operative times, and achieves similar bone healing rates as ICBG. Participants will be randomly assigned to one of two groups. One group will receive alveolar bone grafting using a mixture of DBM and a BMP sponge packed into the cleft defect after closure of the nasal floor mucosa. The other group will undergo the conventional procedure using bone harvested from the patients iliac crest, with measures taken to control post-operative pain. Both groups receive pre-operative antibiotics and general anesthesia. During the study, researchers will monitor outcomes including health system costs per successful bone graft at one year, graft success, infection, fistula recurrence, revision surgery rates, operative and anesthesia times, pain scores, medication usage, fever, drainage, and emergency room visits up to three months post-surgery. Participation involves surgery and follow-up assessments to evaluate both clinical outcomes and cost effectiveness over time.

CONDITIONS

Brief Title

Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate

Research Team

M

Matthew Greives, MD

T

Tien Do, DO

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