Overview

This trial is active, not recruiting.

Condition alveolar ridge augmentation
Treatments md05, beta-tcp and autologous bone
Phase phase 2
Sponsor Scil Technology GmbH
Collaborator FGK Clinical Research GmbH
Start date January 2005
End date December 2007
Trial size 31 participants
Trial identifier NCT00520377, Scil-MD05-C01, Sinus Lift Study

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
MD05
md05
recombinant human GDF-5 coated onto beta-tricalcium phosphate
(Active Comparator)
Beta-TCP and autologous bone
beta-tcp and autologous bone
beta-tricalcium phosphate and autologous bone

Primary Outcomes

Measure
Area of newly formed mineralised bone tissue (%) as assessed by histomorphometry.
time frame: Within 4 months after surgery

Secondary Outcomes

Measure
evidence of uncompromised healing
time frame: January 2008

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Pilot Study on Safety and Efficacy of MD05 in Comparison With Beta-TCP in Patients Undergoing Sinus Floor Augmentation
Principal investigator Wilfried Wagner, Prof Dr Dr
Trial information was received from ClinicalTrials.gov and was last updated in April 2008.
Information provided to ClinicalTrials.gov by Scil Technology GmbH.