NCT04234971 Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate
| NCT ID | NCT04234971 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Cleft Lip and Palate |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-06-14 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2021-06-14 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Matthew Greives, MD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT04234971 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 15 Years, studying Cleft Lip and Palate. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04234971 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04234971 currently recruiting?
Yes, NCT04234971 is actively recruiting participants. Contact the research team at Matthew.R.Greives@uth.tmc.edu for enrollment information.
Where is the NCT04234971 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT04234971 clinical trial?
NCT04234971 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Matthew Greives, MD at The University of Texas Health Science Center, Houston. The trial plans to enroll 40 participants.