Home › Cleft Lip and Palate › NCT04234971

Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate

Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate: A Randomized Clinical Trial

Who can join

Ages 6 to 15 · All sexes

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

About the study

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.

What is being tested

• Intervention group (DBM/BMP) (drug)
• Control group(autologous ICBG) (drug)

Sponsor: The University of Texas Health Science Center, Houston · Participants: 40 · Started: Jun 14, 2021

Contact the study team

• Matthew Greives, MD · Phone: (713) 500-7275

Official record on ClinicalTrials.gov — NCT04234971

Locations in the U.S.

Conditions

• Cleft Lip and Palate

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.