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

NCT00520377 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2008-04-23

No results posted yet for this study

Summary

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

Conditions

  • Alveolar Ridge Augmentation

Interventions

DRUG

MD05

recombinant human GDF-5 coated onto beta-tricalcium phosphate

DEVICE

Beta-TCP and autologous bone

beta-tricalcium phosphate and autologous bone

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY
  • Scil Technology GmbH

    lead INDUSTRY

Principal Investigators

  • Wilfried Wagner, Prof Dr Dr · Universitätsklinikum Mainz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2007-12-31
Completion
2008-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00520377 on ClinicalTrials.gov