Cost Effectiveness in Alveolar Bone Grafting in Patients with Cleft Lip and Palate: a Randomized Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 15
Healthy Volunteers: f
View:
• Patient with CLP(unilateral or bilateral)
• Radiographically evident open bone defect of the alveolus
• Dentition evaluated by orthodontist and cleared for ABG surgery
Locations
United States
Texas
The University of Texas Health Science Center at Houston
RECRUITING
Houston
Contact Information
Primary
Matthew Greives, MD
Matthew.R.Greives@uth.tmc.edu
(713) 500-7275
Backup
Yvette Boyd
Yvette.J.Boyd@uth.tmc.edu
713-500-7311
Time Frame
Start Date: 2021-06-14
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 40
Treatments
Experimental: Intervention group (DBM/BMP)
Patient undergoes Alveolar bone graft with DBM/BMP
Active_comparator: Control group(autologous ICBG)
Patient undergoes Alveolar Bone Graft with Iliac Crest Bone graft.
Related Therapeutic Areas
Sponsors
Leads: The University of Texas Health Science Center, Houston