NCT04234971PHASE4Recruiting
Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate
The University of Texas Health Science Center, Houston
Start Date
6/14/2021
Completion Date
1/1/2028
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 Criteria
Age Range: 6 years to 15 years
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
Interventions
DRUG
Intervention group (DBM/BMP)
DRUG
Control group(autologous ICBG)
Conditions
Cleft Lip and Palate
Locations
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United States