Evaluating cost effectiveness of bone grafting methods for cleft lip and palate patients
Official title: Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate: A Randomized Clinical Trial
Run by The University of Texas Health Science Center, Houston · NCT04234971 · Data updated 2026-11-12
This study is testing whether new bone grafting methods using BMP and DBM can be more effective and less painful than traditional bone grafts for patients with cleft lip and palate.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 6 Years to 15 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | June 14, 2021 |
| Main results expected | January 1, 2028 |
| Study ends | January 1, 2028 |
| Registry record updated | February 19, 2026 |
| Trial ID | NCT04234971 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with unilateral or bilateral cleft lip and palate who have a radiographically evident open bone defect.
✕Probably not a fit
Patients without cleft lip and palate or those who have previously undergone successful alveolar bone grafting may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial aims to compare the cost effectiveness of using Bone Morphogenic Protein (BMP) and Demineralized Bone Matrix (DBM) against traditional autologous Iliac Crest Bone Graft (ICBG) in patients undergoing alveolar bone grafting for cleft lip and palate. The study will assess whether the BMP/DBM approach leads to lower post-operative pain, shorter surgery times, and comparable bone healing rates. By analyzing these factors, the trial seeks to determine the most efficient and effective treatment option for this patient population.
Why it matters
Potential benefit: If successful, this study could provide a more cost-effective and less painful treatment option for patients with cleft lip and palate.
How similar studies have gone: While similar approaches have been explored, this specific comparison of BMP/DBM versus ICBG in this context is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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The University of Texas Health Science Center at Houston
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Matthew Greives, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Matthew Greives, MD
- Email: Matthew.R.Greives@uth.tmc.edu
- Phone: (713) 500-7275
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study is testing whether doing all the necessary nose and gum repairs in one surgery is better than spreading them out over multiple surgeries for kids with cleft lip and palate.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.