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

Last updated: August 29, 2024
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Intervention group (DBM/BMP)

Control group(autologous ICBG)

Clinical Study ID

NCT04234971
HSC-MS-19-1027
  • Ages 6-15
  • All Genders

Study 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

Inclusion

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

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

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Intervention group (DBM/BMP)
Phase: 4
Study Start date:
June 14, 2021
Estimated Completion Date:
January 01, 2026

Connect with a study center

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

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