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

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Jan 15, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at two different methods for a surgical procedure called alveolar bone grafting, which is often needed for children with cleft lip and palate. The researchers want to see if using a special type of bone material called Bone Morphogenic Protein (BMP) combined with Demineralized Bone Matrix (DBM) is more cost-effective and can help patients experience less pain after surgery compared to using their own bone from the hip, known as Iliac Crest Bone Graft (ICBG). They will also check if both methods heal the bone similarly.

To participate in this trial, patients need to be between 2 and 18 years old and have a cleft lip and palate with a specific type of bone defect. They should also have been evaluated and approved by an orthodontist for the surgery. Participants can expect to be involved in a study that may help improve surgical options for future patients, and they will receive care from experienced medical professionals throughout the process. Importantly, the trial is currently recruiting participants, and it welcomes patients of all genders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient with CLP(unilateral or bilateral)
• • Radiographically evident open bone defect of the alveolus
• • Dentition evaluated by orthodontist and cleared for ABG surgery
• Exclusion Criteria:
• • Patients without CLP
• • Previous failed repair of alveolar cleft
• • Patients who have previously undergone successful ABG
• • Patients without an alveolar defect
• • Patients whose parents refuse to consent to randomization
• • Patients who have a syndromic CLP