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

Recruiting now · Phase 4

Conditions studied: Cleft Lip and Palate

In brief

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.

Key facts

Study ID

NCT04234971

Run by

The University of Texas Health Science Center, Houston

People needed

40

Starts

2021-06-14

Expected to finish

2028-01-01

Last updated by the study team

2026-02-19

Who can join

Age: 6 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient with CLP(unilateral or bilateral)
• Radiographically evident open bone defect of the alveolus
• Dentition evaluated by orthodontist and cleared for ABG surgery

You may not qualify if…

• 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

Where it is running

• The University of Texas Health Science Center at Houston — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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