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

RecruitingPhase 4Ages 6 Years - 15 YearsAllThe University of Texas Health Science Center, Ho…
NCT04234971 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Intervention group (DBM/BMP)
  • Control group(autologous ICBG)
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Where

1 site
The University of Texas Health Science Center at Houston
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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