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NCT04234971 · ClinicalTrials.gov registry record · Phase 4
Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate
A Phase 4 study of Cleft Lip and Palate, sponsored by The University of Texas Health Science Center, Houston.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04234971: Recruiting Phase 4 study of Cleft Lip and Palate, sponsored by The University of Texas Health Science Center, Houston.
NCT04234971 is a Phase 4 study of Cleft Lip and Palate that is actively recruiting participants, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 40 participants, below the 216-participant average among 5 other Cleft Lip and Palate trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04234971, a Phase 4 study of Cleft Lip and Palate, is actively recruiting participants, sponsored by The University of Texas Health Science Center, Houston.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Health system costs will be reported as the total sum of all costs including incremental surgeon time costs, hospital costs, revision costs, and additional outpatient costs for clinic or ER visits. Bone graft success be defined as no need for a repeat bone graft, as well as by assessment by blinded orthodontist evaluations of the Post op Cone beam computed tomography(CBCT).
Conditions Studied
Interventions
- DRUG Intervention group (DBM/BMP)
- DRUG Control group(autologous ICBG)
Study Locations (1)
Texas
- The University of Texas Health Science Center at Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-06-14 |
| Est. Completion | 2028-01-01 |
| Phase | Phase 4 |
What NCT04234971 shows while recruiting
NCT04234971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 216-participant average among 5 other Cleft Lip and Palate trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Cleft Lip and Palate appearing as the primary indexed condition, and to 2 interventions - of which Intervention group (DBM/BMP) is the first listed.
NCT04234971 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04234971 about?
NCT04234971 is a clinical study titled "Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate". 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 P...
What is the current status of trial NCT04234971?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2021-06-14. Estimated completion is 2028-01-01.
What conditions does trial NCT04234971 study?
This clinical trial studies the following conditions: Cleft Lip and Palate.
What interventions are being tested in trial NCT04234971?
The interventions under investigation include: Intervention group (DBM/BMP) (DRUG), Control group(autologous ICBG) (DRUG).
Who is sponsoring clinical trial NCT04234971?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04234971 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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