Clinical trial NCT00520377: Pilot Study on Safety and Efficacy of MD05 in Comparison With Beta-TCP in Patients Undergoing Sinus Floor Augmentation
Official title: Pilot Study on Safety and Efficacy of MD05 in Comparison With Beta-TCP in Patients Undergoing Sinus Floor Augmentation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alveolar Ridge Augmentation
Keywords: Sinus Lift Surgery
Sinus Floor Augmentation
Insufficient Bone Height
Lead sponsor: Scil Technology GmbH
Sponsor class: INDUSTRY
Collaborators: name: FGK Clinical Research GmbH
First posted: 2007-08-24
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Area of newly formed mineralised bone tissue (%) as assessed by histomorphometry.
timeFrame: Within 4 months after surgery
Secondary outcomes:
measure: evidence of uncompromised healing
timeFrame: January 2008
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Universitätsklinik Erlangen
state: Bayern
city: München
country: Germany
facility: Praxis Dr. Gath
state: Bayern
city: München
country: Germany
facility: IPI München GmbH
state: Bayern
city: Seefeld
country: Germany
facility: Praxis Dr. Schmidinger
state: Bayern
city: Düsseldorf
country: Germany
facility: Universitätsklinik Düsseldorf
state: Nordrhein Westfalen
city: Mainz
country: Germany
facility: Klinikum der Universität Mainz
state: Rheinland Pflaz
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig Holstein
state: Schleswig Holstein
city: Erfurt
country: Germany
facility: Helios Klinik
state: Thüringen
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
affiliation: Universitätsklinikum Mainz
name: Wilfried Wagner, Prof Dr Dr
role: PRINCIPAL_INVESTIGATOR
References: