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Tests treatment safety and results for Cleft Lip and Palate
Official title Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate
ClinicalTrials.gov ID: NCT04234971
What this study is testing
What is Intervention group (DBM/BMP)?
Intervention group (DBM/BMP) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cleft lip and palate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 15
You may be able to join if
- Patient with CLP(unilateral or bilateral)
- Radiographically evident open bone defect of the alveolus
- Dentition evaluated by orthodontist and cleared for ABG surgery
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 15 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.