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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004392-38-GB

Enrollment

Registered

2006-01-13

Start date

2006-01-12

Completion date

Unknown

Last updated

2012-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: Osigraft (TM) Product Name: Osigraft (TM) Product Code: N/A Pharmaceutical Form: Powder for suspension for injection INN or Proposed INN: Eptotermin Alfa CAS Number: BMP-7/OP-1 Other desc

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the trial is to assess the feasibility and quality of newly formed bone under the influence of Osigraft.;Secondary Objective: ;Primary end point(s): Radiographic assessment which is carried out routinely for alveolar cleft patients at 6 months following surgery and applicatin of rhBMP-7.	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026