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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cleft Lip and Palate

Intervention / Treatment
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* Drug: Intervention group (DBM/BMP)
* Drug: Control group(autologous ICBG)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group (DBM/BMP)<br>Patient undergoes Alveolar bone graft with DBM/BMP | Drug: Intervention group (DBM/BMP)<br>* All patients will undergo a standard procedure for exposure of the cleft alveolar defect and closure of all oronasal fistulae. After induction of general anesthesia, the patient will be intubated with an oral ray tube and prepped and draped in sterile fashion. Pre-operative antibiotics will be given to cover oral flora (i.e. Unasyn or clindamycin if penicillin allergy exists). The intra-oral space will be exposed and the nasal floor and palatal mucosa will be primarily closed to create a water-tight space for the graft. The integrity of the nasal floor mucosa will be tested using methylene blue dye. Following closure of the fistula, the alveolar bone graft will be performed. For the treatment group, 10cc of crushed DBM will be mixed with the micro-sized sponge of rh-BMP-2 (Infuse Bone Graft, Medronic, Minneapolis, MN). The sponge and DBM will then be packed into the defect to completely fill the bony space (FIGURE 3). The anterior mucosa will then be closed.<br>|
| Active Comparator: Control group(autologous ICBG)<br>Patient undergoes Alveolar Bone Graft with Iliac Crest Bone graft. | Drug: Control group(autologous ICBG)<br>* The patient will be induced with anesthesia, prepped, and draped. The intra-oral space will be exposed and the nasal floor and palatal mucosa will be primarily closed to create a water-tight space for the graft. The integrity of the nasal floor mucosa will be tested using methylene blue dye. Following closure of the fistula, the alveolar bone graft will be performed.In the control group, the ICBG will be harvested percutaneously using the Accumed bone graft harvesting system. Briefly, an incision will be made in iliac crest and drill bit inserted. Multiple passes of the drill be used to harvest as much autograft bone as possible from the cancellous region of the iliac crest.Following harvest, fibrin glue will be instilled for hemostasis and a Ropivicaine On-Q pain pump inserted for post-operative pain control. The harvest bone graft will be packed into the alveolar defect in a similar fashion and the mucosa closed anteriorly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health system costs per successful bone graft. | 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). | One year post graft | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft Success | Graft success as indicated by number of patients that did not have exposure of graft as assessed by post op CBCT | 3 months post graft | 
| Infection | Graft success as indicated by number of patients that had no graft infection as assessed by post op CBCT | 3 months post graft | 
| Fistula Recurrence | Graft success as indicated by number of patients that had no recurrence of oronasal fistula as assessed by post op CBCT | 3 months post graft | 
| Rate of Revision ABG | Graft success as indicated by number of patients that had no no need for repeat bone graft as assessed by post op CBCT | 3 months post graft | 
| Operative Time | Total time for operation | 1 day | 
| Anesthesia Time | total time of anesthesia | 1 day | 
| Post Operative Pain Scores | Change in pain as assessed by the numeric Rating Scale(NRS) for pain. The NRS total score ranges form 0(no hurt) to 10(hurts worst) | 1 week post operatively | 
| Pain Medication Usage | Total dose of post-operative narcotics used | 1 week post operatively | 
| Post Op Fever | Number of patients with the post operative complication fever | 3 months | 
| Drainage from Fistula | Number of patients with the post operative complication drainage from donor site or alveolar site | 3 months | 
| Post Op ER Visits | Number of patients with the post operative complication ER or primary care visits | 3 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alveolar bone graft, Bone Morphogenic Protein, Demineralized Bone Matrix, cleft lip