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

• Status: Recruiting
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to evaluate if the use of Bone Morphogenic Protein(BMP)/Demineralized Bone Matrix (DBM) versus the use of autologous Iliac Crest Bone Graft (ICBG) will result in an increase in total cost effectiveness for patients undergoing alveolar bone graft (ABG) for Cleft Lip and Palate (CLP) and to see if patients who are treated with DBM/BMP will have reduced post-operative pain scores,reduced operative times,and similar rates of bone healing compared to conventional ICBG.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston

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