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

Scil Technology

Status and phase

Unknown

Phase 2

Conditions

Alveolar Ridge Augmentation

Treatments

Device: Beta-TCP and autologous bone

Drug: MD05

Study type

Interventional

Funder types

Industry

Identifiers

NCT00520377

Sinus Lift Study

Scil-MD05-C01

Details and patient eligibility

About

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

Enrollment

31 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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