Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 6 to 15

Evaluating cost effectiveness of bone grafting methods for cleft lip and palate patients

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

Run by The University of Texas Health Science Center, Houston · NCT04234971 · Data updated 2026-11-12

This study is testing whether new bone grafting methods using BMP and DBM can be more effective and less painful than traditional bone grafts for patients with cleft lip and palate.

Quick facts

PhasePhase 4
Study typeInterventional
Ages6 Years to 15 Years
SexAll
Enrollment40 (estimated)
SponsorThe University of Texas Health Science Center, Houston
Academic / other
Locations1 site (Houston, Texas)
StatusRecruiting
StartedJune 14, 2021
Main results expectedJanuary 1, 2028
Study endsJanuary 1, 2028
Registry record updatedFebruary 19, 2026
Trial IDNCT04234971 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with unilateral or bilateral cleft lip and palate who have a radiographically evident open bone defect.

Probably not a fit

Patients without cleft lip and palate or those who have previously undergone successful alveolar bone grafting may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to compare the cost effectiveness of using Bone Morphogenic Protein (BMP) and Demineralized Bone Matrix (DBM) against traditional autologous Iliac Crest Bone Graft (ICBG) in patients undergoing alveolar bone grafting for cleft lip and palate. The study will assess whether the BMP/DBM approach leads to lower post-operative pain, shorter surgery times, and comparable bone healing rates. By analyzing these factors, the trial seeks to determine the most efficient and effective treatment option for this patient population.

Why it matters

Potential benefit: If successful, this study could provide a more cost-effective and less painful treatment option for patients with cleft lip and palate.

How similar studies have gone: While similar approaches have been explored, this specific comparison of BMP/DBM versus ICBG in this context is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.