RecruitingPhase 4NCT04234971

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

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


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

40 participants

Start Date

Jun 14, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 YearsMax Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Control group(autologous ICBG) and a drug called Intervention group (DBM/BMP) for people with cleft lip and palate. The study is currently recruiting participants at 1 location. People eligible for this study include aged 6 Years to 15 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntervention 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.

DRUGControl 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.


Locations(1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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NCT04234971


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