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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-15
SponsorThe University of Texas Health Science Center, Houston

About this 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.

Eligibility criteria

Qualifiers

Patient with CLP(unilateral or bilateral)

Radiographically evident open bone defect of the alveolus

Dentition evaluated by orthodontist and cleared for ABG surgery

Disqualifiers

Patients without CLP

Previous failed repair of alveolar cleft

Patients who have previously undergone successful ABG

Patients without an alveolar defect

Trial design

Treatments tested in this trial

  • Intervention group (DBM/BMP)
  • Control group(autologous ICBG)

Treatment groups

40 Participants
are divided into 2 treatment groups