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

Phase 4

Recruiting

• Conditions: Cleft Lip and Palate

• Registration Number: NCT04234971
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-21
• Study Start: 2021-06-14
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-11
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Health system costs per successful bone graft.	One year post 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).

Secondary Outcome Measures

Name	Time	Method
Operative Time	1 day	Total time for operation
Anesthesia Time	1 day	total time of anesthesia
Graft Success	3 months post graft	Graft success as indicated by number of patients that did not have exposure of graft as assessed by post op CBCT
Infection	3 months post graft	Graft success as indicated by number of patients that had no graft infection as assessed by post op CBCT
Fistula Recurrence	3 months post graft	Graft success as indicated by number of patients that had no recurrence of oronasal fistula as assessed by post op CBCT
Rate of Revision ABG	3 months post graft	Graft success as indicated by number of patients that had no no need for repeat bone graft as assessed by post op CBCT
Post Operative Pain Scores	1 week post operatively	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)
Pain Medication Usage	1 week post operatively	Total dose of post-operative narcotics used
Post Op Fever	3 months	Number of patients with the post operative complication fever
Drainage from Fistula	3 months	Number of patients with the post operative complication drainage from donor site or alveolar site
Post Op ER Visits	3 months.	Number of patients with the post operative complication ER or primary care visits