A Phase 4 interventional study of Intervention group (DBM/BMP) and Control group(autologous ICBG) in Cleft Lip and Palate, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to participants aged 6 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by The University of Texas Health Science Center, Houston · Phase 4, Interventional, and Health services research
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.
168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's planned enrollment of 40 is above the median of 30 across 116 interventional studies indexed under Cleft Lip.
Browse Cleft Lip studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
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Exclusion Criteria:
Patient undergoes Alveolar bone graft with DBM/BMP
Drug: Intervention group (DBM/BMP)
Patient undergoes Alveolar Bone Graft with Iliac Crest Bone graft.
Drug: Control group(autologous ICBG)
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.
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.
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).
Time frame: One year post graft
Graft Success
Graft success as indicated by number of patients that did not have exposure of graft as assessed by post op CBCT
Time frame: 3 months post graft
Infection
Graft success as indicated by number of patients that had no graft infection as assessed by post op CBCT
Time frame: 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
Time frame: 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
Time frame: 3 months post graft
Operative Time
Total time for operation
Time frame: 1 day
Anesthesia Time
total time of anesthesia
Time frame: 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)
Time frame: 1 week post operatively
Pain Medication Usage
Total dose of post-operative narcotics used
Time frame: 1 week post operatively
Post Op Fever
Number of patients with the post operative complication fever
Time frame: 3 months
Drainage from Fistula
Number of patients with the post operative complication drainage from donor site or alveolar site
Time frame: 3 months
Post Op ER Visits
Number of patients with the post operative complication ER or primary care visits
Time frame: 3 months.
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2021 (actual). Primary completion is estimated for Jan 2028, 78 months after the start.
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