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

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.

Study Overview

• Status: Recruiting
• Conditions: Cleft Lip and Palate
• Intervention / Treatment: Drug: Intervention group (DBM/BMP); Drug: Control group(autologous ICBG)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Matthew Greives, MD; Phone Number: (713) 500-7275; Email: Matthew.R.Greives@uth.tmc.edu
• Study Contact Backup: Name: Yvette Boyd; Phone Number: 713-500-7311; Email: Yvette.J.boyd@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Yvette Boyd; Phone Number: 713-500-7311; Email: Yvette.J.boyd@uth.tmc.edu
      • Contact: Matthew Greives, MD; Phone Number: 713-500-7275; Email: Matthew.R.Greives@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Matthew Greives, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 21, 2020

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: cleft lip; alveolar bone graft; Bone Morphogenic Protein; Demineralized Bone Matrix
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: HSC-MS-19-1027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No