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

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

Study Overview

• Status: Unknown
• Conditions: Alveolar Ridge Augmentation
• Intervention / Treatment: Drug: MD05; Device: Beta-TCP and autologous bone

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Charité Universitätsmedizin Berlin
  • Bayern
    • Erlangen, Bayern, Germany, 91054
      • Universitätsklinik Erlangen
    • München, Bayern, Germany, 80336
      • Praxis Dr. Gath
    • München, Bayern, Germany, 81925
      • IPI München GmbH
    • Seefeld, Bayern, Germany, 82229
      • Praxis Dr. Schmidinger
  • Nordrhein Westfalen
    • Düsseldorf, Nordrhein Westfalen, Germany, 40225
      • Universitätsklinik Düsseldorf
  • Rheinland Pflaz
    • Mainz, Rheinland Pflaz, Germany, 55131
      • Klinikum der Universität Mainz
  • Schleswig Holstein
    • Kiel, Schleswig Holstein, Germany, 24105
      • Universitatsklinikum Schleswig Holstein
  • Thüringen
    • Erfurt, Thüringen, Germany, 99089
      • Helios Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; MD05	Drug: MD05; recombinant human GDF-5 coated onto beta-tricalcium phosphate
Active Comparator: 2; Beta-TCP and autologous bone	Device: Beta-TCP and autologous bone; beta-tricalcium phosphate and autologous bone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area of newly formed mineralised bone tissue (%) as assessed by histomorphometry.	Within 4 months after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
evidence of uncompromised healing	January 2008

Collaborators and Investigators

• Sponsor: Scil Technology GmbH
• Collaborators: FGK Clinical Research GmbH
• Investigators: Principal Investigator: Wilfried Wagner, Prof Dr Dr, Universitätsklinikum Mainz

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): December 1, 2007
• Study Completion (Anticipated): May 1, 2008

Study Registration Dates

• First Submitted: August 23, 2007
• First Submitted That Met QC Criteria: August 23, 2007
• First Posted (Estimate): August 24, 2007

Study Record Updates

• Last Update Posted (Estimate): April 23, 2008
• Last Update Submitted That Met QC Criteria: April 22, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Keywords: Sinus Floor Augmentation; Sinus Lift Surgery; Insufficient Bone Height
• Other Study ID Numbers: Scil-MD05-C01; Sinus Lift Study