The feasibility of using Bone Morphogenetic Protein (rhBMP-7) for reconstruction of alveolar cleft - The use of BMP for alveolar reconstructio

• Conditions: Autogenous bone graft harvested from the iliac crest is utilised as a gold standard for alveolar reconstruction. However, the harvesting of the bone graft is associated with morbidity which could be avoided with the use of BMP. This investigation will be conducted on 30 children who are referred to our care for reconstruction of their alveolar cleft. Clinicians, researchers and members of the Scottish Managed Clinical Network, Cleft Lip & Palate, has approved this investigation.

• Registration Number: EUCTR2005-004392-38-GB
• Lead Sponsor: HS Greater Glasgow/Glasgow University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-13
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients require reconstruction of alveolar cleft.
2. A full understanding of the aim of the study to the nature of the medicinal product.
3. Age restriction is 8-14 years.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients who are taking medication that has an effect on bone turnover such as calcitonin or steroids.
2. Patients suffering from metabolic bone diseases.
3. Patients with a known sensitivity to any component of Osigraft.
4. Patients with immunosuppression.
5. Patients with an active infection at or near the cleft.
6. Patients with tumours at or near the cleft.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified