Actively Recruiting
Cost Effectiveness in Alveolar Bone Grafting for Cleft Lip and Palate: A Randomized Clinical Trial
Led by The University of Texas Health Science Center, Houston · Updated on 2026-02-19
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the cost effectiveness of using Bone Morphogenic Protein (BMP) combined with Demineralized Bone Matrix (DBM) compared to the traditional autologous Iliac Crest Bone Graft (ICBG) in patients with Cleft Lip and Palate (CLP) undergoing alveolar bone graft (ABG) surgery. This trial aims to see if BMP/DBM reduces post-operative pain, shortens operative times, and achieves similar bone healing rates as ICBG. Participants will be randomly assigned to one of two groups. One group will receive alveolar bone grafting using a mixture of DBM and a BMP sponge packed into the cleft defect after closure of the nasal floor mucosa. The other group will undergo the conventional procedure using bone harvested from the patient's iliac crest, with measures taken to control post-operative pain. Both groups receive pre-operative antibiotics and general anesthesia. During the study, researchers will monitor outcomes including health system costs per successful bone graft at one year, graft success, infection, fistula recurrence, revision surgery rates, operative and anesthesia times, pain scores, medication usage, fever, drainage, and emergency room visits up to three months post-surgery. Participation involves surgery and follow-up assessments to evaluate both clinical outcomes and cost effectiveness over time.
CONDITIONS
Brief Title
Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with unilateral or bilateral cleft lip and palate
- Radiographically confirmed open bone defect of the alveolus
- Dentition evaluated and cleared for alveolar bone graft surgery by an orthodontist
- Age between 6 and 15 years
You will not qualify if you...
- Patients without cleft lip and palate
- Previous failed repair of alveolar cleft
- Patients who have previously undergone successful alveolar bone graft
- Patients without an alveolar defect
- Parents refuse consent to randomization
- Patients with syndromic cleft lip and palate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo alveolar bone graft surgery using either DBM/BMP or iliac crest bone graft under general anesthesia.
1 surgical visit (in-person)
Duration - 3 months
Participants are monitored post-operatively for pain, infection, fistula recurrence, and graft success.
Approximately 3 visits over 3 months (in-person)
Duration - Up to 1 year post graft
Participants are followed to assess health system costs and overall success of the bone graft.
1 annual visit (in-person)
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Matthew Greives, MD
T
Tien Do, DO
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here