RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-06-14
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04234971

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.

Ages Eligible for Study:6 Years to 15 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Patient with CLP(unilateral or bilateral)
  2. * Radiographically evident open bone defect of the alveolus
  3. * Dentition evaluated by orthodontist and cleared for ABG surgery
  1. * Patients without CLP
  2. * Previous failed repair of alveolar cleft
  3. * Patients who have previously undergone successful ABG
  4. * Patients without an alveolar defect
  5. * Patients whose parents refuse to consent to randomization
  6. * Patients who have a syndromic CLP

Contacts and Locations

Study Contact

Matthew Greives, MD
CONTACT
(713) 500-7275
Matthew.R.Greives@uth.tmc.edu
Yvette Boyd
CONTACT
713-500-7311
Yvette.J.Boyd@uth.tmc.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-14
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2021-06-14
Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

  • alveolar bone graft
  • Bone Morphogenic Protein
  • Demineralized Bone Matrix
  • cleft lip

Additional Relevant MeSH Terms

  • Cleft Lip and Palate