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

The University of Texas System (UT)

Status and phase: Enrolling; Phase 4

Conditions: Cleft Lip and Palate

Treatments: Drug: Intervention group (DBM/BMP); Drug: Control group(autologous ICBG)

Study type: Interventional

Funder types: Other

Identifiers

NCT04234971

HSC-MS-19-1027

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Intervention group (DBM/BMP)

Experimental group

Description:

Patient undergoes Alveolar bone graft with DBM/BMP

Treatment:

Drug: Intervention group (DBM/BMP)

Control group(autologous ICBG)

Active Comparator group

Description:

Patient undergoes Alveolar Bone Graft with Iliac Crest Bone graft.

Treatment:

Drug: Control group(autologous ICBG)