Pilot Study on Safety and Efficacy of MD05 in Comparison With Beta-TCP in Patients Undergoing Sinus Floor Augmentation

Alveolar Ridge Augmentation Clinical Trial

Official title:

Pilot Study on Safety and Efficacy of MD05 in Comparison With Beta-TCP in Patients Undergoing Sinus Floor Augmentation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00520377
• Other study ID #: Scil-MD05-C01
• Secondary ID: Sinus Lift Study
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 23, 2007
• Last updated: April 22, 2008
• Start date: January 2005
• Est. completion date: May 2008

Study information

• Verified date: April 2008
• Source: Scil Technology GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The primary objective is the area of newly formed bone (%) as assessed by histomorphometry with either MD05 or beta-TCP.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: May 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients requiring two-stage unilateral maxillary sinus floor augmentation (sinus lift) in case of insufficient bone height in the area of the posterior maxilla, prior to insertion of dental implants

• Residual bone height at the site of planned implantation > 1 mm and < 5 mm

• Male and female outpatients, 18 to 75 years old

• Female patients must be infertile (either sterilized or postmenopausal). If a patient's menopausal status at screening is uncertain, levels of follicle stimulating hormone (FSH) should be determined. Patients with an FSH level > 25 IU/l and absence of menstrual bleeding > 6 months will satisfy the definition of postmenopausal status.

• Patient has given informed consent.

Exclusion Criteria:

• Women of childbearing potential, lactating women

• Participation in another clinical study within 30 days prior to study start

• Previous participation in this study

• Last dental extraction (maxilla, posterior to canine) within the last 3 months

• Failed sinus lift surgery and previous eradictive maxillary sinus surgery

• Simultaneously bilateral sinus lift

• Legal incompetence or restricted legal competence

• Alcoholism, drug dependency, smoking

• Acute or chronic infection at the application site, e.g., sinusitis

• Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)

• Severe allergic rhinitis which requires permanent medication (Rosenlicht 1999)

• Known intolerance of or hypersensitivity to beta-TCP or rhGDF?-5

• Presence of local or systemic malignant disease or history of local or systemic malignant disease in the past 5 years

• Patients requiring chemo- or radiotherapy

• Previous or current radiotherapy of the head

• Chronic liver disorder

• Impaired renal function

• Uncontrolled, insulin-dependent diabetes mellitus

• Clinically relevant symptoms of thyroid dysfunction

• Severe hypertension (RRdiast > 110 mmHg);

• Clinically relevant cardiovascular disease

• Systemic bone disease or illness having influence on bone metabolism,

• Clinically relevant blood coagulation disorder,

• Leukopenia < 3.500 leukocytes/µL

• Previous or current treatment with systemic corticosteroids

• Previous or current therapy with drugs having any influence on bone metabolism

• Previous or current treatment with immunosuppressant medication

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alveolar Ridge Augmentation

Intervention

Drug:
• MD05
recombinant human GDF-5 coated onto beta-tricalcium phosphate

Device:
• Beta-TCP and autologous bone
beta-tricalcium phosphate and autologous bone

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	Universitätsklinik Düsseldorf	Düsseldorf	Nordrhein Westfalen
Germany	Helios Klinik	Erfurt	Thüringen
Germany	Universitätsklinik Erlangen	Erlangen	Bayern
Germany	Universitätsklinikum Schleswig Holstein	Kiel	Schleswig Holstein
Germany	Klinikum der Universität Mainz	Mainz	Rheinland Pflaz
Germany	IPI München GmbH	München	Bayern
Germany	Praxis Dr. Gath	München	Bayern
Germany	Praxis Dr. Schmidinger	Seefeld	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
Scil Technology GmbH	FGK Clinical Research GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area of newly formed mineralised bone tissue (%) as assessed by histomorphometry.		Within 4 months after surgery	No
Secondary	evidence of uncompromised healing		January 2008	Yes