NCT00520377

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2005

Typical duration for phase_2

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

April 23, 2008

Status Verified

April 1, 2008

Enrollment Period

2.9 years

First QC Date

August 23, 2007

Last Update Submit

April 22, 2008

Conditions

Alveolar Ridge Augmentation

Keywords

Sinus Lift SurgerySinus Floor AugmentationInsufficient Bone Height

Outcome Measures

Primary Outcomes (1)

  • Area of newly formed mineralised bone tissue (%) as assessed by histomorphometry.

    Within 4 months after surgery

Secondary Outcomes (1)

  • evidence of uncompromised healing

    January 2008

Study Arms (2)

1

EXPERIMENTAL

MD05

Drug: MD05

2

ACTIVE COMPARATOR

Beta-TCP and autologous bone

Device: Beta-TCP and autologous bone

Interventions

MD05DRUG

recombinant human GDF-5 coated onto beta-tricalcium phosphate

1
Beta-TCP and autologous boneDEVICE

beta-tricalcium phosphate and autologous bone

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Universitätsklinik Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Praxis Dr. Gath

München, Bavaria, 80336, Germany

Location

IPI München GmbH

München, Bavaria, 81925, Germany

Location

Praxis Dr. Schmidinger

Seefeld, Bavaria, 82229, Germany

Location

Universitätsklinik Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Klinikum der Universität Mainz

Mainz, Rheinland Pflaz, 55131, Germany

Location

Universitätsklinikum Schleswig Holstein

Kiel, Schleswig-Holstein, 24105, Germany

Location

Charité Universitätsmedizin Berlin

Berlin, State of Berlin, 12203, Germany

Location

Helios Klinik

Erfurt, Thuringia, 99089, Germany

Location

Study Officials

  • Wilfried Wagner, Prof Dr Dr

    Universitätsklinikum Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 23, 2007

First Posted

August 24, 2007

Study Start

January 1, 2005

Primary Completion

December 1, 2007

Study Completion

May 1, 2008

Last Updated

April 23, 2008

Record last verified: 2008-04

Locations

DE(9)