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Pilot Study on MD05 in Comparison With Open Flap Debridement in Patients Undergoing Periodontal Surgery

NCT00519155 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2008-04-23

No results posted yet for this study

Summary

The purpose of the study is to gain experience of safety and efficacy with MD05 in man in alveolar bone regeneration.

Conditions

  • Alveolar Bone Loss
  • Periodontal Bone Loss

Interventions

DRUG

MD05 and open flap debridement

recombinant human GDF-5 coated onto ß-tricalcium phosphate

PROCEDURE

Open flap debridement

Open flap debridement alone

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • Scil Technology GmbH

    lead INDUSTRY

Principal Investigators

  • Anton Sculean, Prof. · Department of Periodontology; Radboud University Medical Center

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
2007-07-31
Primary Completion
2008-10-31
Completion
2008-11-30

Countries

  • Hungary

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 NCT00519155 on ClinicalTrials.gov