Actively Recruiting

Phase 4
Age: 6Years - 15Years
All Genders
NCT04234971

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

Led by The University of Texas Health Science Center, Houston · Updated on 2026-02-19

40

Participants Needed

1

Research Sites

341 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 6Years - 15Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient with cleft lip and palate (unilateral or bilateral)
  • Radiographically confirmed open bone defect of the alveolus
  • Dentition evaluated and cleared by an orthodontist for alveolar bone graft surgery
Not Eligible

You will not qualify if you...

  • Patients without cleft lip and palate
  • Previous failed repair of alveolar cleft
  • Patients who have previously undergone successful alveolar bone graft
  • Patients without an alveolar defect
  • Parents who refuse to consent to randomization
  • Patients with syndromic cleft lip and palate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

M

Matthew Greives, MD

CONTACT

T

Tien Do, DO

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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