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

Cleft Lip and Palate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04234971
• Other study ID #: HSC-MS-19-1027
• Status: Recruiting
• Phase: Phase 4
• Start date: June 14, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: December 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Matthew Greives, MD
• Phone: (713) 500-7275
• Email: Matthew.R.Greives[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Infection	Graft success as indicated by number of patients that had no graft infection as assessed by post op CBCT	3 months post graft
Secondary	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
Secondary	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
Secondary	Operative Time	Total time for operation	1 day
Secondary	Anesthesia Time	total time of anesthesia	1 day
Secondary	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
Secondary	Pain Medication Usage	Total dose of post-operative narcotics used	1 week post operatively
Secondary	Post Op Fever	Number of patients with the post operative complication fever	3 months
Secondary	Drainage from Fistula	Number of patients with the post operative complication drainage from donor site or alveolar site	3 months
Secondary	Post Op ER Visits	Number of patients with the post operative complication ER or primary care visits	3 months.