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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 6 Years and 15 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)
Masking Description
To prevent surgeon bias in operative time and therefore cost, randomization assignments will be concealed at the beginning of surgery. The surgeon will start with closure of the oronasal fistula first. Once that is completed, the envelope will be opened and reveal the type of bone graft selected. The surgeon will then either harvest the additional ICBG or open the packets for the DBM/BMP and pack the selected type of bone into the alveolus. Outcomes assessor including orthodontist and clinical research evaluator will be blinded to treatment arms.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Intervention group (DBM/BMP) 		Patient undergoes Alveolar bone graft with DBM/BMP
  • Drug: Intervention group (DBM/BMP)
    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.
Active Comparator
Control group(autologous ICBG) 		Patient undergoes Alveolar Bone Graft with Iliac Crest Bone graft.
  • Drug: Control group(autologous ICBG)
    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.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Matthew Greives, MD
(713) 500-7275
Matthew.R.Greives@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Matthew Greives, MD
(713) 500-7275
Matthew.R.Greives@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.