RECRUITING

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

Description

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.

Study Overview

Study Details

Study overview

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.

Cost Effectiveness in Alveolar Bone Grafting in Patients with Cleft Lip and Palate: a Randomized Clinical Trial

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

Condition
Cleft Lip and Palate
Intervention / Treatment

-

Contacts and Locations

Houston

The University of Texas Health Science Center at Houston, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patient with CLP(unilateral or bilateral)
  • * Radiographically evident open bone defect of the alveolus
  • * Dentition evaluated by orthodontist and cleared for ABG surgery
  • * 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

Ages Eligible for Study

6 Years to 15 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The University of Texas Health Science Center, Houston,

Matthew Greives, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

2026-01-01