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Use of Bone Morphogenic Protein 7 in the atrophic maxilla - CH. MAX-FACC 01/2007

Use of Bone Morphogenic Protein 7 in the atrophic maxilla - CH. MAX-FACC 01/2007

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-002123-32-IT
Enrollment
10
Registered
2007-06-19
Start date
2007-05-15
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

bone atrophy of the maxilla MedDRA version: 6.1 Level: PT Classification code 10031248

Interventions

Trade Name: OSIGRAFT*USO INTRAOSSEO FL 1G Pharmaceutical Form: Dental powder INN or Proposed INN: Other drugs for disorders of the musculo-skeletal system Concentration unit: g gram(s) Concentration

Sponsors

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria:  Patients who need bilateral sinus lift for implant rehabilitation  Male or Female over the age of 18  Patients without sinus deseases or other invalidate deasease Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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: Tobacco abuse Women pregnant Diabetes Known hypersensibility towards trial drug or collagen Concomitant use of Biphosphonates

Design outcomes

Primary

MeasureTime frame
Main Objective: Implant survival and success, sinus lifted bone histologic and histomorphometic evaluation 4 month after surgery;Secondary Objective: Sinus lifted bone gain evaluation, sinus lifted bone resorption;Primary end point(s): Implant survival and success, sinus lifted bone histologic and histomorphometic evaluation 4 month after surgery.

Countries

Italy

Outcome results

None listed

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