Evaluating cost effectiveness of bone grafting methods for cleft lip and palate patients
Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate: A Randomized Clinical Trial
PHASE4 · The University of Texas Health Science Center, Houston · NCT04234971
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 | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Years to 15 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04234971 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with unilateral or bilateral cleft lip and palate who have a radiographically evident open bone defect.
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.
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 performed: While similar approaches have been explored, this specific comparison of BMP/DBM versus ICBG in this context is relatively novel.
Eligibility criteria
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 this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cleft Lip and Palate, alveolar bone graft, Bone Morphogenic Protein, Demineralized Bone Matrix, cleft lip